Tendon

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To read the full report click here: RepliCel’s Cutting-Edge Advancements

The following has been published in the Financial Post:

There is enormous interest in the worlds of medicine and esthetics in the promise of regenerative medicine. From cellular replacement techniques for treating Parkinson’s disease to collagen-producing cell injections for wound healing and rejuvenating aging skin, significant steps are being made towards the commercialization of cell therapies. These changes are going to attract major industry players who are constantly on the watch for the latest technologies in development.

Vancouver-based RepliCel Life Sciences Inc. (TSX.V: RP) is a company that is already capturing industry attention. Its unique research into cells from hair follicles could play an integral part in accelerating the repair of tendons, damaged skin and pattern baldness.

David Hall, chief executive officer of RepliCel, describes the premise behind its research as being “elegant in its simplicity.” For example, to treat chronically injured tendons, a patient’s collagen-producing cells (fibroblasts) are isolated from a small biopsy taken from the nape of the patient’s neck, replicated and then injected directly into a damaged tendon to stimulate the stalled healing process leading to structural rehabilitation.

“These isolated fibroblast cells are prolific in their ability to produce Type 1 collagen, the key and missing cell in the stalled healing cycle of a tendon. This same principle holds for aged and sun-damaged skin where the collagen-producing fibroblasts have been damaged by ultraviolet light over time. Our focus is to address indications where there is a deficit of active fibroblasts,” Hall explains. “As injuries occur and people age, their ability to produce collagen and other critical proteins is depleted through repeated injury, sun damage, aging and other factors. Our technology, as it’s proposed, will jump-start the healing process.”

One focus for RepliCel is on clinical trials for chronic tendon injuries, an area of major concern for employers, compensation boards, athletes, active aging populations and the military. Early clinical work using cells isolated from the skin returned excellent results, and RepliCel believes that it has improved the technology even further by using healthier cells isolated from hair follicles. Trials planned for the fall of 2014 will return results in 2015.

The power of the RepliCel approach lies in the fact that treatment utilizes a person’s own cells, thereby reducing risk of complications, notes Lee Buckler, managing director for Cell Therapy Group, a Vancouver-based regenerative industry consulting company. “Taking a patient’s own cells, replicating them in a regulated facility and then returning them to the body minimizes safety risks.”

The markets RepliCel is addressing with their products are significant, he adds. “Their platform, built around two different hair follicle cell populations, could be instrumental in skin applications for burns, acne scarring or aging, in addition to the market for musculoskeletal injuries. It could also play a key role in disrupting the micro-transplant and hair rejuvenation business for pattern baldness.”

Regenerative medicine technologies are now solidly on the radar of big pharmaceutical, biotech and health care companies, Buckler says. “Most life science company executives now believe that cell-based products will represent a new way of delivering therapies to patients. As such, they’re now starting to invest in technologies to make sure they have a horse in the race.”

“Most of the top companies like Pfizer, Janssen, GSK, Novartis, Celgene now have internal and/or external cell therapy programs,” Buckler adds. “Other companies are investing in bringing manufacturing technologies to the sector and even companies not traditionally in health care, like Nestlé and L’Oreal, have established their own research institutes for these cell-based programs. If you look at the industry’s development pipeline, most every condition is being pursued as a target for a cell therapy.”

RepliCel’s current pipeline includes trials for tendinosis, pattern baldness and treatments for aging and sun-damaged skin in various stages of development. Hall estimates that data from the tendon and dermal programs will be available to support licensing discussions by 2015, and pattern baldness in 2016.

“Having this many trials is pretty impressive for a small company,” Hall says. “Our model has always been to develop products, demonstrate efficacy and then license to large pharma or cosmetics firms who can do the final commercialization. We want to be the research and development engine that creates revenues from licences and royalties. In fact, Shiseido Company of Japan has already partnered with us on our pattern baldness product. They acquired an exclusive geographic license for Asia.”

Having spent much of his career researching treatments for tendinosis, Dr. Jack Taunton, professor at the University of British Columbia faculty of medicine’s sports medicine division, says regenerative therapy holds great promise when dealing with chronic, long-term injuries. “We’ve dealt with a number of these types of injuries caused by overuse or repetitive strain in thousands of patients. Typically treatments have included physiotherapy, ice, anti-inflammatory’s, dextrose and PRP [platelet-rich plasma] injections. Yet, we still have a significant population of patients that do not get better.” He is hopeful that the upcoming RepliCel trials will improve those numbers given that hair follicle fibroblasts produce the amount of Type 1 collagen needed for fundamental repair of the tendon. “The potential to save millions of dollars in treatment of chronic tendon disorders is huge. It’s extremely exciting.”

Dr. Ross Davidson, an orthopedic surgeon and director of post-graduate sports medicine at the University of Auckland in New Zealand has treated countless athletes with chronic overuse injuries throughout his career. “I do see a huge potential for this. It has been a pleasant surprise to see the amount of collagen these fibroblasts produce for repairing tendons. It’s a big change from other treatments being released. If it works — and I believe it will — it will reduce the number of surgeries significantly.”

Beyond its clinical trials, the success of RepliCel’s products will be put in the hands of licensing partners which have the infrastructure to support commercialization, says Mark Landy, director of research for senior medical technology and regenerative medicine analyst for Summer Street Research in Boston. The good news is that the industry is not having to wait too long for the clinical trials to get proof of concept. “Having data coming in 2015 and 2016 enables the company to accelerate licensing.”

He believes RepliCel has a significant opportunity ahead given that its regenerative therapy approach addresses extremely large markets that are ready for solutions not provided by today`s treatments. “The industry as a whole has gone beyond the fears around regenerative and genetic engineering and is seeing its value. We now know we can take certain cells from the body and safely put them in certain areas. It’s a notion that goes back to bone marrow transplants and implants. The opportunities — and the markets — for regenerative medicine are very, very large.”

With results from clinical trials on the horizon, Hall is confident things are moving forward as they should. “We’ve been quietly building the fundamentals of this business – forging deals with major players, building up a diversified portfolio and strengthening our management team. Every step we take is incrementally adding value to the shareholders and furthering therapies for patients.”

hopeful that the upcoming RepliCel trials will improve those numbers given that hair follicle fibroblasts produce the amount of Type 1 collagen needed for fundamental repair of the tendon. “The potential to save millions of dollars in treatment of chronic tendon disorders is huge. It’s extremely exciting.”

This story was produced by Postmedia’s advertising department on behalf of Market One Media Group for commercial purposes. Postmedia’s editorial departments had no involvement in the creation of this content.

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New in BioWorld, the latest in RepliCel’s cell therapy trials and what they could mean for improving Achilles tendinosis, aging and sun-damaged skin.

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VANCOUVER, BC – September 4, 2014 – RepliCel Life Sciences Inc. (OTCQB: REPCF) (TSXV: RP), a clinical stage regenerative medicine company focused on the development of autologous cell therapies, will be presenting at the Rodman & Renshaw Global Investment Conference at the New York Palace Hotel on Tuesday, September 9, 2014 at 9:15 AM local time in the Adam’s Salon on the fourth floor.

The 20 minute presentation by Mr. David Hall, CEO, will include an update on the Company’s current programs for chronic Achilles tendinosis (RCT-A-01), sun damaged and aging skin (RCS-01) and pattern hair loss (RCH-01). All of RepliCel’s autologous cell product candidates address medical conditions caused by a deficit of healthy, functioning cells required for normal healing and function.

The presentation will be webcast and posted on Rodman & Renshaw’s website shortly after the live presentation at http://wsw.com/webcast/rrshq24/repcf and on RepliCel’s website under the Investor section at http://www.replicel.com/investors/corporate-publications/.

About RepliCel Life Sciences
RepliCel is a regenerative medicine company focused on developing autologous cell therapies that address diseases caused by a deficit of healthy cells required for normal healing and function such as chronic tendinosis, damaged skin and pattern baldness. The company’s RCT-01 and RCS-01 cell therapies are designed to treat chronic tendinosis and damaged or aging skin respectively, using fibroblasts isolated from the sheath of the hair follicle. Another of the company’s pipeline products, RCH-01 for the treatment of pattern baldness, is manufactured from cells derived from the hair follicle dermal cup. Shiseido Company, Limited has an exclusive geographic license for RCH-01 in certain Asian countries including Japan, China and South Korea. All product candidates are based on RepliCel’s innovative technology which utilizes cells isolated from a patient’s own healthy hair follicles to address specific cellular deficits. For additional information please visit www.replicel.com.

For more information please contact:

David M. Hall, Chief Executive Officer
Tammey George, Director of Communications
RepliCel Life Sciences
604-248-8696
tg@replicel.com

INVESTOR RELATIONS:
Christina Cameron, Investor Relations
christina@clcameron.com

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

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CCRM and RepliCel to Partner on Development of Cell Therapies for Tendon Repair

VANCOUVER, BC and Toronto, ON – September 3, 2014 – RepliCel Life Sciences Inc. (TSXV: RP) (OTCQB: REPCF), a clinical stage regenerative medicine company focused on the development of autologous cell therapies, is the newest member of the Centre for Commercialization of Regenerative Medicine’s (CCRM) industry consortium.

“The company is pleased to have been accepted as a member of CCRM’s industry consortium,” states David Hall, CEO of RepliCel. “CCRM represents one of the leading global entities in the area of regenerative medicine and being part of its industry consortium embeds us in an exemplary network. Their broad industry activities and, in particular, their regulatory services are an important current asset to RepliCel. Furthermore, RepliCel is pursuing CCRM as a secondary manufacturing site for the company’s fibroblast platform, which is a key step in demonstrating technology transfer, as well as risk mitigation away from a single site cell replication model.”

CCRM is currently engaged in providing RepliCel with contract regulatory services including documentation and filings related to RepliCel’s RCT-A-01 product for chronic Achilles tendinosis. This program is the subject of a planned clinical trial in Canada to start in 2014 that will involve clinical testing to address chronic tendinosis, a degenerative disease of the tendon caused by a cycle of injury, improper healing and re-injury until there are very few pain free and functional periods. Despite the body’s attempts to heal itself, complete healing of the tendon is never achieved, potentially due to a deficit of type I producing fibroblast cells needed to support the healing process.

RCT-A-01 will attempt to address this cellular deficit by providing an injection of a patient’s own fibroblasts to the site of the injury. Collagen-producing fibroblast cells will be isolated from hair follicles taken by a punch biopsy from the back of the patient’s scalp. These cells will then be grown in controlled processes. The new cells are injected directly into the wounds within the tendon via ultra-sound imaging. After injections are performed, patients return to the clinic for assessments of safety, function and pain, as well as changes in tendon thickness, echo texture, interstitial tears and neovascularity (growth of new blood vessels).

This treatment is designed to provide the necessary number of fibroblast cells to initiate and complete the disrupted healing process leading to a normally functioning tendon with higher tensile strength. Further indications will include patellar tendinosis, or jumper’s knee, and lateral elbow tendinosis.

“RepliCel is one of a small, but quickly growing, class of companies emerging in the Canadian landscape that are leading the way with clinical-stage development of cell-based therapies being developed, tested, and hopefully commercialized first in Canada,” says Michael May, President and CEO of the Centre for Commercialization of Regenerative Medicine. “CCRM is pleased to play a pivotal role in supporting RepliCel’s efforts to develop a new class of therapies for patients and, in the process, contribute to the growth and success of this emerging segment of the biotechnology industry.”

About the Centre for Commercialization of Regenerative Medicine
CCRM, a Canadian not-for-profit organization funded by the Government of Canada’s Networks of Centres of Excellence program and six academic partners, supports the development of technologies that accelerate the commercialization of stem cell- and biomaterials-based technologies and therapies. A network of academics, industry and entrepreneurs, CCRM aims to translate scientific discoveries into marketable products for patients. CCRM launched in Toronto’s Discovery District on June 14, 2011. CCRM is hosted by the University of Toronto.

CCRM has three core development themes: cell reprogramming and engineering; cell manufacturing; and, biomaterials and devices to carry out projects commissioned by academia and industry. CCRM has a fully resourced, 6,000 square foot development facility where all development work takes place.

CCRM’s industry consortium currently numbers nearly 40 companies representing the key sectors of the industry: devices, therapeutics, reagents and cells as tools. Please visit http://www.ccrm.ca/industry-consortium to see a complete list of CCRM’s members.

For more information please contact:

CENTRE FOR COMMERCIALIZATION OF REGENERATIVE MEDICINE
Stacey Johnson, Director of Communications
647-309-1830
Stacey.johnson@ccrm.ca
www.ccrm.ca

REPLICEL LIFE SCIENCES INC.
David Hall, CEO
dh@replicel.com

Tammey George, Director of Communications
604-248-8696
tg@replicel.com

Christina Cameron, Investor Relations
christina@clcameron.com

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To read the full report click here: Mark Landy on New Growth Ideas for Biotech Investors

The following is an excerpt from The Life Sciences Report, with Mark Landy’s comments on RepliCel:

“RepliCel Life Sciences Inc. is at the forefront of the utilization of stem cells to treat disorders and defects.”

TLSR: Your universe of coverage includes medical technology and regenerative
medicine. Would you talk about some names, please? Do you have a regenerative
medicine story you can share?

ML: While I don’t formally cover RepliCel Life Sciences Inc. (RP:TSX.V;
REPCF:OTCQB), I do find it an interesting and exciting story. I have been doing
diligence on the company to learn more about its technology and opportunities. It
falls into a new category of medicine that is very intriguing to me: regenerative
medicine and gene therapy. RepliCel and another company I follow, Harvard
Apparatus Regenerative Technology Inc. (HART:NASDAQ), are at the forefront of
the utilization of stem cells to treat disorders and defects, which is definitely the
future of medicine.

TLSR: RepliCel has two proposed Phase 2 trials with its RCT-01 (non-bulbar
dermal sheath fibroblasts) cells, which should be initiated before the end of this
year. One trial will be for the Achilles tendinosis indication. I realize that as a Phase
2, this is not designed to be a pivotal trial. But will 82 patients, 41 of whom will
receive RCT-01, be enough to get an indication of efficacy?

ML: To me, the real questions are: What could go wrong and is it safe? My
hypothesis is: Not a whole lot can go wrong and the therapy will be safe, as the
company is using autologous cells. Autologous cells are taken from an individual
and returned to the body. They are a perfect immunological match, and if handled in
a safe and appropriate manner, should not cause the patient any harm. At this
stage, I think what we are all interested in is the safety of RepliCel’s therapy, and I
do not see a lot of risk.

With that said, you are right: The numbers in this study may be too small to determine scientific evidence of efficacy. However, companies like to get some understanding
or signal indicating that there could be efficacy, and they like to learn how to power
larger studies. Also, and more important, in some countries, the pathway to
approval and commercialization for stem cell therapy is being altered so that
companies only need to generate safety data in trials. Then, within a specified
amount of time, they must provide data on efficacy to maintain the therapies on the
market. This is an opportunity that RepliCel can take advantage of, shortening the
cost and time to market in some countries.

TLSR: The other proposed Phase 2 study will be in androgenic alopecia (male
pattern baldness). This study will be with a total of 160 male patients—two
experimental arms, one with 66 single injections and one with 66 repeat injections,
with a 28-patient control arm. What could this trial tell us?

ML: RepliCel could get an indication of efficacy, and could also use this study to
solidify a commercial partner with the financial resources to take the product to
market. This is RepliCel’s strategy: to develop new products and therapies, and
then license the commercial rights to companies with deep pockets and strong
distribution networks.

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For the full article click here: Alan Leong Interview on Niche Biotech Prospects

life-scineces-report

Read below for an excerpt from Street Wise Reports on Alan Leong’s comments about RepliCel:

TLSR: You mentioned RepliCel in regenerative medicine. Tell me your growth theory for this company.

AL: RepliCel came onto our radar when we were at the Biotech Showcase and JP Morgan Healthcare Conference back in January. The company is very early in development and caught our eye for a couple of reasons.

One, the cells are derived from cells in the hair follicle. Two, the company is competing in less crowded niches—baldness or alopecia, and tendinosis. It’s very interesting that these hair follicle-derived cells appear to have advantageous properties when applied to healing tennis elbow, Achilles tendinosis and similar complaints. The early results are interesting and positive.

“The day is coming in which we will be able to pick a very specific niche or cluster and provide very effective treatments for more defined diseases.”

RepliCel is going to launch two Phase 2 trials this year. For those thinking of investing, the company is in a low-cash position, and is risky. RepliCel behaves like a private company in a lot of ways, because it is raising money to fund some of the next trials. One of the scientists involved with the technology, Kevin McElwee from the University of British Columbia, has an excellent reputation, not just among scientists but also among clinicians who are into hair restoration. Usually, companies joining the regenerative medicine space target major organs and systems. RepliCel, on the other hand, is going after niche indications that give it a much clearer playing field. There was one direct cell therapy competitor, the Aderans Research Institute, out there in the baldness space, but it abandoned the field a few months ago.

TLSR: RepliCel’s technology is autologous. The cells are harvested from the back of the patient’s scalp, and are expanded and processed ex vivo. The harvest and readministration of these cells by injection for alopecia, given that it is a two-step procedure, is about even in clinical complexity to hair plug therapy. Will this therapy for baldness be superior to hair plug therapy, which we know can be painful for the patient?

AL: All things being otherwise equal, patients will be more sold on RepliCel’s therapy than on the hair transplant procedure. With a hair transplant, the physician typically has to implant thousands of units from one part of the head to another. That requires incredible dexterity and takes several hours. In fact, that is why robotics are getting involved—the physician endures incredible repetitive strain. In addition, physicians are digging out not just follicles but a little bit of muscle, too, and placing that into the patient.

Another thing that makes RepliCel’s therapy attractive is that, if you look at surveys or talk to people who are losing hair, the concept of having these injections is very palatable. This possibly could expand the market. Finally, if you look at surveys, the percentage of men who say they would give up a significant portion of their wealth to have their hair restored is astounding.

TLSR: Back on May 20, the company said its licensing partner, Shiseido Company Ltd., was opening a new cell processing facility at the Kobe Biomedical Innovation Cluster in Japan. Does it make sense to process and expand those cells so far away?

AL: Shiseido, a major cosmetics company, is licensing RepliCel’s hair regeneration technology in the largest parts of Asia. It has more than $7B in revenue. In Japan, companies that get involved in pharmaceuticals aren’t like the ones here. For instance, you have major pharmaceutical companies that also make beer, and cosmetic companies doing major research. Shiseido’s new facility is not just a tiny laboratory. It represents a major cell therapy investment. Shiseido’s investment into the collaboration is a form of validation for RepliCel.

TLSR: In mid-June, RepliCel announced it had closed on the third and final tranche of a nonbrokered capital raising that it originally announced at the end of March. Each unit sold for $0.75, and that includes one warrant that could be exercised for $1/share in the first year and $1.25 in year two. The total of these tranches was only about $3.9M, which is not a lot of money. How much dilution are RepliCel investors in for in the future?

AL: It’s a good question, because the dilution could be serious. RepliCel is trying to raise cash in fits and gulps to get it through the next set of trials and raise the company’s valuation. I think that’s part of the rationale behind why the Phase 2 trials are confined in terms of geography. The company wants to put out strong proof of concept and raise the valuation while still making progress on the commercial side. There’s no doubt about it: There’s a balancing act going on here. RepliCel is also trying to raise money through unconventional sources, including governmental sources of funding. We shall see.

TLSR: Alan, I have read that 11 of 12 patients in the Phase 1 Achilles tendinosis trial had what the company calls “satisfactory outcomes,” but those were with adipose-derived cells and not with cells derived from the patient’s hair follicles, which will be used in Phase 2.

AL: That’s correct. The tendinosis indication has had the Phase 1 proof-of-concept study performed, but the Phase 2 study will incorporate some tweaks to the procedure.

TLSR: Is the lead indication at RepliCel Achilles tendinosis or alopecia?

AL: If you asked the company’s CEO, David Hall, I think he would say he’s looking at both of them. Right now, you would have to pick alopecia as positioned to be RepliCel’s lead indication, because a) it has the Phase 2 data, and b) it has the alliance with Shiseido, which also will be advancing work in its labs back in Japan.

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By Martin Rogers
June 8, 2014 11:14 PM
Yahoo Sports

SAO PAULO – To a medical student, tendinosis is a non-inflammatory condition involving a previously injured tendon that heals with weak collagenous fibers, low weight-bearing resistance and has a high risk of future injury.

To the United States national team, it might mean surviving the Group of Death at this summer’s World Cup.

As is so often the case in the breathless build-up to a World Cup, tiny details come into stark focus and this time it is the turn of Portugal’s Cristiano Ronaldo and his troubled left knee to face the scrutiny of a global soccer audience.

After missing two training sessions with “left patellar tendinosis” and taking a limited individual role (no tackling, no kicking with his left foot) in several others, Ronaldo returned to full practice over the weekend, but is still being monitored with extreme caution by Portugal national team officials.

All of which is of natural interest to Jurgen Klinsmann’s Americans, who will meet Portugal in Manaus on June 22 in what is the second and arguably most important of its Group G matchups.

While the U.S. is trying not to be distracted by factors outside its control, both the players and Klinsmann must surely have wondered how different it’d be to take on Portugal without Ronaldo, the current World Footballer of the Year and most destructive performer on the planet right now.

Portugal head coach Paulo Bento has been getting snappy about the issue; perhaps unsurprisingly since he has been asked about little else for the past week.

“When he is ready to play is a decision that will be made just like any other player, regardless of who it is,” Bento said.

Ronaldo’s return to training was announced with a simple statement from the Portuguese soccer federation, stating only that he had been “integrated” with the rest of the squad.

That news was greeted with relief and excitement in Portugal but tendinosis, often confused with tendinitis, is not a condition to be taken lightly and can cause significant complications in athletes.

High-tech solutions may not be far away. David Hall is CEO of Replicel, a company seeking to revolutionize tendon treatment by developing a regenerative cell therapy system using material taken from the sheath surrounding each patient’s own hair follicles and injecting it into the damaged area.

That treatment, however, is still in testing. For now, Hall told Yahoo Sports in a telephone interview, there is no replacement for rest and recuperation – but with the World Cup kicking off later this week and Portugal’s opener against Germany on June 16, time is a luxury Ronaldo does not have.

“The guy has to be rested and healed completely,” Hall said. “By definition any soccer player or any professional sport – basketball, volleyball – the tendon has to be healthy to take the stress. If you get into an incomplete healing cycle, you just can’t heal properly.

“There is an inflection point where for high performance athletes [unless rested] there is never going to be enough potential strength to maintain the same level of play.”

The difficult and potentially frustrating part for Ronaldo is that he may stop feeling pain, stiffness or any form of real discomfort, long before the injury has actually healed.

For any soccer player, especially one with the World Cup around the corner, the temptation is always to get back onto the field the moment the pain ceases.

Hall highlighted the case of tennis star Rafael Nadal, who won his ninth French Open title on Sunday. Nadal is back to his best now, but when he tried to hurry back from knee tendon problems in 2012 it ultimately led to a much longer layoff.

The Ronaldo situation certainly makes things very interesting for the Americans. There is a school of thought in media circles that Klinsmann built his squad primarily with Portugal in mind, perhaps reasoning that to stand a chance of progressing the side must beat Ghana in its first game anyway, and will be a heavy underdog in game three against Germany.

Klinsmann selected a young and speedy 23-man roster, which could serve the dual purpose of targeting the somewhat lumbering Portuguese defensive line and having quick legs with which to keep as much constant pressure on Ronaldo as possible.

It’ll be another two weeks before we know if it works, or how complete a recovery Ronaldo makes as the biggest event in soccer approaches.

Meanwhile the world keeps watching and learning more about the term tendinosis than it ever thought it would have to.

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Despite us both living in the Vancouver area and both being involved in cell therapy, I didn’t meet David Hall until we were both in La Jolla late last year for the Alliance for Regenerative Medicine‘s Stem Cell on the Mesa meeting. Since then we’ve been keeping in close contact and I have had opportunity to learn a lot more about him, his team, RepliCel, and the company’s technology.

The company is by all appearances a company on the tail end of a number of significant transitions in terms of its structure, finance, clinical pipeline, and even the breadth of its underlying technology. The company is now unveiling RepliCel 2.0 (my term, not theirs) which builds on the company’s core expertise and platform technology but combines newly added assets and clinical strategies that create end-to-end solutions and multiple pillars around which shareholder value is being created.

David presents a sound logic for the transitions through which he has taken the company in the past 18 months and the pace of that change. He does, perhaps more than many CEO’s I have had the opportunity to interview, present a strong and focused vision for the company with a clear goal and a well-defined pathway for how he intends to get the company there. From my vantage point, this vision permeates into most aspects of the company from clinical trial design, to patent strategy, to defining collaborations, and even recruiting.

Suffice it to say I have been increasingly impressed by what I see and welcome the opportunity to share the interview below with you. I hope you enjoy learning a little more about RepliCel as much as I have.

CTB: Tell us a little about your background, David, and how you got involved in a cell therapy company?

DH: RepliCel is treating cellular deficits in two main areas. The first is addressing conditions where there is a deficit of healthy functioning fibroblasts such as chronic tendinosis and damaged skin.

The second is in treating pattern baldness where there is a deficit of dermal sheath cup cells that are responsible for maintaining a hair follicle cycle of fiber production.

In addition, we have developed cell manufacturing technology and procedures to support the potential commercialization of these indications as well as specialised delivery devices which in themselves are unique and have the potential for licensing for other medical and cosmetic uses. We believe the manufacturing and delivery assets are very important to the company as you need to be able to demonstrate scalability and commercial delivery.

CTB: What is the company’s technology?

DH: RCH-01 is our treatment for pattern baldness. This technology specifically focuses on replacing a deficit of healthy active dermal sheath cup cells (DSCs). Our product thesis is that these DSC cells control and maintain the population of dermal papillae (DP) cells in a hair follicle and the number of DPs determine the length and thickness of the hair fibre. In patients with pattern baldness (men and women), DSCs are compromised by the androgen hormone for no known reason. It is kind of like the reverse of unwanted or aggressive hair growth. Some people have five-o-clock shadows when they are 15 and others don’t shave until they are 20+. In pattern baldness, the androgen hormone compromises hair growth. RCH-01 addresses the deficit of the active DSC cells in the areas of pattern baldness in the scalp.

The RCT family of products* are for the treatment of chronic tendinosis including Achilles, patellar and both golfer’s and tennis elbow. In each case we are addressing a deficit of healthy active fibroblasts. The scientific thesis is that this chronic disease is the result of incomplete healing cycles due to a deficit of healthy functioning fibroblasts. Our early human clinical work on chronic tendinosis was done by our collaborator, Dr. David Connell, using fibroblasts isolated from the dermis. Our program is based on using fibroblasts isolated from the hair follicle due to their ability to express higher levels of type I collagen than dermal fibroblasts. Type I collagen is the main cell constituent of a tendon. (*RCT-A-01, RCT-P-01, RCT-G-01 and RCT-T-01)

RCS-01 is focused on replacing damaged or non-functioning fibroblasts in the dermis. Fibroblasts damaged by UV irradiation, smoking and other factors stop producing healthy amounts of collagen and the constituents of the skin’s extracellular matrix. As a result, the skin loses its texture. Similarly, acne and burn scars are targets for us to deliver highly expressive fibroblasts to initiate remodelling of the damaged skin.

The supporting manufacturing technology is also a critical asset to the company as we believe our process is scalable.

In addition, we have developed a very unique injection cell injection device for dermal injections for both our derm and pattern baldness program. This device minimizes shear force, optimizes staged cell delivery, and has a built in freezing element that obviates the need for any kind of anesthetic and can control both volume and depth of injection.

CTB: Where are you doing your trials? Why Europe and Canada?

DH: All of our trials are being conducted under the terms of reference from the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Each trial is designed to meet these international standards of which all of the western nations are members. As such, all of our data up to Phase 2 are admissible towards Phase 3 pivotal programs in each jurisdiction.

Our RCS-01 trial is being done in Germany. The co-founder of the Company Dr. Rolf Hoffmann, is located in Germany and he is leading this initiative. Similarly, our RCH-1 treatment is being conducted in Germany at the Charité Hospital in Berlin. The Charité is one of the largest teaching and research hospitals in Europe. In addition, the technology itself was first developed in Dr. Hoffmann and Dr. McElwee’ s lab at the University of Marburg in Germany. There is history with these technologies in Germany and in addition, the cells are being processed by our contract manufacturer in Austria.

The clinical trial for RCT-A-01 will be conducted at the University of British Columbia because it is a world centre of excellence for sports medicine research including tendinosis. We have three very special advisers leading the development of the clinical trial protocol including Dr. Ross Davidson, Dr. Jack Taunton and Dr. David Connell. Each of them are key opinion leaders in sports medicine. It is also convenient to have this trial in our own city, but it was not the deciding factor. Reputation, skills and the ability to recruit patients were the deciding factors. The cells will be processed in Austria; however, we are moving to bring online a second contract facility validated in North America at the Centre for Commercialization for Regenerative Medicine in Toronto.

CTB: What is the strategy for the U.S. market?

DH: The US market will be addressed from two angles. First, we are presenting our fibroblast program to the US military under their peer reviewed medical research program. The DoD has a great interest in musculoskeletal research to deal with damaged tendons and skin. We believe our programs are ideally suited for their needs and are preparing filings for funding for clinical programs both in Canada and the US. The second approach is to undertake phase 2 clinical work on other target tendons in the US after we have gotten our RCT-A-01 program launched. Importantly, all of our trials are being conducted under ICH standards with the US regulatory pathways in mind.

CTB: Tell us about the deal you did recently with Shiseido and what your drivers were for that kind of deal?

DH: In 2013 we completed a geographic license with the Shiseido Company. Shiseido has its own hair research lab and they had come to the conclusion that our approach was the leading cell therapy technology for treating pattern baldness.

We were interested in doing a geographic license for Japan and parts of Asia for three main reasons. The first was to have a third party validation of our science and technology which is always important to a start-up company. The second was to be partnered with a large company whom had the resources (both human and financial) to conduct their own clinical program which along with our program would more than double the data being collected as we work towards establishing our dosing and other protocols for the technology in humans. Thirdly, Shiseido has committed to cell therapy in a significant manner including having commissioned and now opened a purpose-built cell processing centre in Kobe Japan, in the heart of the country’s regenerative medicine initiative.

Our ongoing collaboration will see technology improvements shared between parties. Financially, we received $4 million up front, future milestones totaling approximately $30 million as well as middle single digit royalties on sales. We are very pleased with our collaboration with Shiseido. They are a focused and dependable collaborator.

CTB: From our perspective, the company is significantly under-exposed both in the regenerative medicine industry and investment communities. Can you give us a sense of why you think that might be and your plans in that regard?

DH: Every company has its own chronological pathway to develop a profile in its industry and in the public domain. During the later stages of 2012 and through 2013 RepliCel was very concentrated on completing the Shiseido transaction as well as completing the filing of PCT patent applications on its fibroblast platform. Until we had completed the task of protecting our expanded technology, it did not serve the company to disclose these activities.

Now in 2014, we are completing the next round of financing, pushing hard on our clinical filings to launch 3 clinical trials and now have the freedom to discuss our programs. As such, we are going to be out in the public domain at conferences and doing roadshows in order to get the RepliCel story known and followed both in industry and in the capital markets.

CTB: While many of the companies in the cell therapy sector are focused on indications like cardiovascular disease, oncology, autoimmune disorders, or diseases of the central nervous system, RepliCel is going after sports injuries, baldness, and wrinkles. Do you see these indications as low-hanging fruit? Do these indications battle problems of lower-margin and/or reimbursement challenges?

DH: I would agree that our programs are low hanging fruit in the regenerative medicine business and that is an attractive distinction. Furthermore, as an autologous therapy, there is less risk of rejection than an allogeneic therapy.

Our therapies are designed to simply multiply a patient’s particular cells that are in deficit and then deliver it to the area of deficit. We are not differentiating or inducing cell change, we are simply letting the cells do what they normally do when placed in the area of the wound or damage.

A lot of regenerative medicine is focused on very complex processes that take a source cell and then engage in extensive cell manipulation and/or differentiation. While these treatments are going to arrive in the future, today they are very difficult therapies to perfect both in assuring that the cell differentiations are exact and controlled and that the cells are delivered in volume and stay and function where they are needed. Our process is just simpler. So, yes, this is low hanging fruit in terms of safety risk and the commercial development timeline.

In terms of margins, we are quite confident in our ability to demonstrate manufacturing scalability. In terms of reimbursement, initially we have only one product that would need pharmacoeconomic validation and that is the tendon program. However, we know that we can replicate and deliver a tendon program at a reasonable cost and that there is no current clinically established solution for chronic tendinosis. Therefore, we do not anticipate any problem pricing at a good margin. In terms of the derm program, the initial focus is a cosmetic therapy and I think pricing a solution for sun damaged skin, wrinkles, etc. should not be an issue. A treatment with good efficacy will have no problem getting a premium price. In terms of margins on a treatment for pattern baldness, it would be priced against the current standard of care which is hair transplant surgery. And at that price, we can make good margins.

CTB: Many of the cell therapy products already approved are in the musculoskeletal, dermatology, and wound repair space and none are a run-away success. Does it worry you to be also focused on these areas for your near-term opportunities?

DH: That is a statement on the relative efficacy and difficulty of delivery. Approval does not necessarily equate to commercial success. We believe that our programs will have significant efficacy for their targeted indications, be easily delivered and they will become the gold standards. But that is the nature of product development; you have go out and demonstrate efficacy! One comment on wound repair is that we are not at this time interested in pursuing open wound repair as that space has many solutions ranging from complex cell therapies to medical devices. It is a crowded space and we prefer at this time to prove our platforms where we are confident in our success and are not populated by other treatments.

CTB: Your initial focus is on autologous applications of the hair follicle-derived cells, what are plans to address some of the commercial (cost) challenges presented by autologous cell therapies already on the market?

DH: As mentioned above, we are focused in parallel to our clinical development programs, on developing a scalable process for our cell manufacturing. We see this as a process engineering program and not a development process requiring scientific breakthroughs. This development program is underway. It is also true that we believe that our hair follicle derived cells are immune privileged and that in the future, our technologies could well become an allogeneic offering. But that is down the road.

CTB: Few companies of RepliCel’s size and market cap are simultaneously tackling multiple products in clinical trials let alone also the concurrent development of a proprietary delivery device. Some might argue it would be more prudent to preserve capital to ensure you have what it takes to move one product further down the line. Can you give us a sense of your why you prefer this multi-pronged strategy?

DH: Our programs are inherently cheaper to develop and test than more complex cell therapies and for that matter, new chemical entities or biologics. We are simply expanding a patient’s cells and giving them back to them. It is just cheaper to do than other therapies. As such, we can undertake more programs and I would argue that for shareholders, more shots on goal helps to mitigate risks associated with clinical programs. We believe we have a single focus on leveraging our core expertise around cells derived from the hair follicle organ and finding meaningful clinical applications for those cells. Optimizing the manufacturing and delivery of those cells just makes sense as part of the risk mitigation and value optimization of those assets.

CTB: To those investors interested in the regenerative medicine and cell therapy sector, where does RepliCel fit in the industry and how do you think it stacks up against sector comparables as an investment opportunity?

DH: I would characterize RepliCel as a mid-stage development company that exists between earlier approved products like Apligraf and Dermagraft for wound healing, and much more complex cell therapy clinical development programs. There are other mid-stage programs like Athersys’ MultiStem and Mesoblast’s Mesenchymal Precursor Cells. However, I would argue that our simple cell replication process of a target cell deficit is simpler to manufacture and deliver than many cell therapies. So, I would characterize our development programs as lower risk. Nevertheless, I would also say to investors that regenerative medicine is going to be a huge field in the future as science and technologies evolve. This industry will be delivering incredible medical solutions for patients in the future.

CTB: Talk to us a little about the stock. It’s very lightly traded on both the Toronto venture exchange and over-the-counter bulletin board. What’s the plan going forward in terms of its listing and liquidity?

DH: Yes, it is true our trading has been low. That is a direct function of our tightly held stock, (management, founders, etc., own approximately 45% of the stock) and the fact that we were very focused in 2103 on our partnership and the patent filings. As discussed above, we are now launching our story on a focused basis that will see the company out on road shows delivering its message to potential investors. We think that RepliCel is an attractive and unknown story which will have a good reception. That effort is focused on addressing the valuation and liquidity. In terms of listing, the natural progression as we develop assets and valuation is to up list which we will be pursuing.

CTB: Where do you see RepliCel in 18-24 months?

DH: On a clinical basis, we will have data in both our tendon and derm programs and will be closing in on the clinical trial data for our treatment for pattern baldness. We should at that time be initiating at least one other tendon program and a phase 2 derm program. We will have developed clinical protocols for two new indications for our fibroblast platform (not yet being disclosed due to patent work) and we will have demonstrated scalability of our manufacturing platform. If we accomplish this as planned, we will have established an extremely valuable group of assets.

CTB: Thank you, David, for the opportunity to spend some time learning more about RepliCel and your plans for the company.

www.celltherapyblog.com hosted by www.celltherapygroup.com

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FINANCIAL POST ARTICLE PUBLISHED ON FEBRUARY 25, 2014

Imagine using healthy cells from your body to heal areas in which other cells are damaged or deficient. That’s what RepliCel Life Sciences Inc. (TSXV: RP) expects to do by developing a new cell-based treatment for chronic tendinosis, in which a patient’s own fibroblast cells from their hair follicles are harvested, replicated, and then reintroduced into the damaged areas within the tendon via ultrasound, which “jump starts” the wound-healing cycle. These cells are replicated but are not altered in any way, so there is no safety issue involved in the re-introduction of a patient’s own cells.

Tendinosis is the result of repetitive injuries and incomplete healing cycles that lead to a degenerative breakdown of the collagen tissue within a tendon, which inevitably leads to pain, dysfunction, and often rupture. The company estimates the potential market for the treatment of tendinosis is in excess of $3 billion per year.

RepliCel’s fibroblast technology uses nonbulbar dermal sheath (NBDS) cells, which are prolific in their expression of type I collagen and are key to creating a complete healing cycle within the damaged and degenerated tendon. These cells are taken from the back of the patient’s scalp with the use of a small punch biopsy. The NBDS cells are unique in that they are capable of dividing and renewing for long periods. In a laboratory, this process can yield millions of cells. These cells, which make up the sheath of a hair follicle, are healthy throughout a person’s life as they are in a continued state of renewal.

“It takes us about five to six weeks to replicate the cells and the cells are returned to the patient via a minimally invasive ultrasound guided injection directly to the area of damage and it takes about six months to return the patient to full functionality,” said RepliCel President and CEO David Hall in a recent interview. Mr. Hall has more than 20 years of biotech experience and is the former Chief Financial Officer at Angiotech Pharmaceuticals Inc.

The Company’s phase 2 tendinosis fibroblast program is being followed into human clinical trials with a treatment for UV damaged and aging skin using the same technology platform. RepliCel has also developed unique injector devices to support the delivery of its treatments. The company expects to complete the development of its injector device, which is programmable to depth and dose and has built-in cooling that replaces the need for an anesthetic. This device could also find a market in the delivery of other cosmetic dermal injectors. The device is expected to be commercialized in the next year, providing additional licensing opportunities for the company and asset value accretion.

RepliCel’s technologies carry issued and filed patent applications. Furthermore, the Company’s cell manufacturing technology is protected by trade secrets and is unique in its ability to quickly replicate fibroblast cells versus other replication technologies. RepliCel is also entering into a Phase 2 clinical trial for the treatment of pattern baldness using another cell isolated from the hair follicle. The technology was the subject of a Q2, 2013 Collaboration and Technology Development Transfer Agreement with Shiseido Company, Limited of Japan, the third-largest cosmetic company in world, in which Shiseido paid RepliCel an upfront fee of $4,120,400 for a geographic license including Japan, China and the ASEAN countries. Shiseido will initiate its own clinical program in Japan, providing two parallel clinical trials. RepliCel plans to initiate a Phase 2 trial for chronic tendinosis and a Phase 1 trial for aging and damaged skin in 2014 with results expected in 2015.

“I expect we can get an approval for treating chronic tendinosis within three years,” Mr. Hall added. RepliCel had $3.2 million in cash and equivalents as of September 30, 2013, and has a cash burn rate of approximately $200,000 per month. The company has 48,118,609 issued and outstanding common shares as of February 1, 2014, and after its listing on the TSX-V in February of this year its stock has surged 50% to its recent price of 90 cents a share.

About RepliCel Life Sciences:
RepliCel Life Sciences Inc. (TSXV: RP) is a clinical stage biopharmaceutical company focused on developing autologous cell therapies that treat functional cellular deficits. RepliCel Tendon-01 (RCT-01) is a cell therapy for the treatment of chronic tendon injuries. RepliCel Hair-01 (RCH-01) is a cellular treatment for androgenetic alopecia (pattern baldness). Shiseido Company, Limited has an exclusive geographic license for RCH-01 in certain Asian countries including Japan, China and South Korea. Both product candidates are based on RepliCel’s innovative technology which utilizes cells isolated from a patient’s own healthy hair follicles to address specific cellular deficits. For additional information please visit www.replicel.com.

Disclosure
RepliCel Life Sciences is a featured sponsored company and has paid SmallCapPower.com a fee for coverage.

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Vancouver, Canada – January 9, 2014 – RepliCel Life Sciences Inc. (OTCQB: REPCF) (CSE: RP), a clinical stage biopharmaceutical company focused on developing therapies to address conditions associated with cellular deficits, today announced that CEO David Hall will present at the Biotech Showcase™ 2014 investor and partnering conference to be held January 13–15, 2014 in San Francisco, at the Parc 55 Wyndham Hotel. Mr. Hall will discuss RepliCel’s autologous cell therapies for treating tendinosis and androgenetic alopecia at 2:30 p.m. PST on January 13, 2014. A copy of the presentation will be added to RepliCel’s website and can be viewed here once posted.

About the Biotech Showcase
The Biotech Showcase is an investor and partnering conference devoted to providing private and public biotechnology and life sciences companies with an opportunity to present to, and meet with, investors and pharmaceutical executives.

About RepliCel Life Sciences
RepliCel is a clinical stage biopharmaceutical company focused on developing autologous cell therapies. RepliCel Tendon-01 (RCT-01) is a cell therapy for the treatment of chronic tendon injuries. RepliCel Hair-01 (RCH-01) is a cellular treatment for androgenetic alopecia (pattern baldness). Shiseido Company, Limited has an exclusive geographic license for RCH-01 in certain Asian countries including Japan, China and South Korea. Both product candidates are based on RepliCel’s innovative technology which utilizes cells isolated from a patient’s own healthy hair follicles to address specific cellular deficits. For additional information please visit www.replicel.com.

CORPORATE CONTACT:
Tammey George, Director of Communications
RepliCel Life Sciences
604-248-8696
tg@replicel.com

INVESTOR CONTACTS:
Westwicke Partners, LLC
Stefan Loren, Ph.D., Managing Director
(443) 213-0507
sloren@westwicke.com

Robert H. Uhl, Managing Director
(858) 356-5932
robert.uhl@westwicke.com

Notice Regarding Forward Looking Statements
This press release contains projections and forward-looking statements, as that term is defined under applicable securities laws. Statements in this press release, which are not purely historical, are forward-looking statements and include the following: (i) that the Company will conduct further human clinical trials; (ii) that ongoing research collaboration will be conducted by the Company and Shiseido for the continued improvement of the technology; (iii) that a commercial, safe and effective hair regenerative treatment will be developed and commercialized; (iv) that the Company and Shiseido will develop further improvements to the technology; (v) that the Company will undertake and enter into development and collaboration agreements for the development of its technologies; and (vi) and that the Company’s technology will rejuvenate damaged hair follicles leading to the growth of new healthy hair fibers. These statements are only predictions and involve known and unknown risks which may cause actual results and the Company’s plans and objectives to differ materially from those expressed in the forward-looking information, including: that negative results from the Company’s clinical trials may impact further clinical trials, development, approval and commercialization of the technology; the effects of government regulation on the Company’s business, including the future development of the technology; risks associated with the Company’s ability to obtain and protect rights to its intellectual property; risks and uncertainties associated with the Company’s ability to raise additional capital; that the Company may not be able to find other parties will to participate in the development and collaboration of its technologies, and other factors beyond the Company’s control. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee future results, levels of activity or performance. Further, any forward-looking statement speaks only as of the date on which such statement is made, and, except as required by applicable law, the Company undertakes no obligation to update any forward-looking statement to reflect events or circumstances after the date on which such statement is made or to reflect the occurrence of unanticipated events. New factors emerge from time to time, and it is not possible for management to predict all of such factors and to assess in advance the impact of such factors on the Company’s business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statement. Readers should consult all of the information set forth herein and should also refer to the risk factor disclosure outlined in the Company’s annual report on Form 20-F for the fiscal year ended December 31, 2012 and other periodic reports filed from time-to-time with the Securities and Exchange Commission on Edgar at www.sec.gov and with the British Columbia Securities Commission on SEDAR at www.sedar.com.

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VANCOUVER, BC – October 30, 2013 – RepliCel Life Sciences Inc. (OTCBB: REPCF) (CNSX: RP), a clinical stage biopharmaceutical company focused on the development of autologous cell therapies for regenerative medicine, today announced the formation of a clinical advisory board (CAB) to support the clinical development of its RCT-01 autologous cell therapy for the treatment of a variety of chronic tendon injuries including Achilles, patellar and elbow tendinosis. The board, chaired by Ross G. Davidson, MBChB, will provide its expertise and guidance on all aspects of the clinical trial program. Additional members include David A. Connell, MBBS, and Dr. Jack E. Taunton, M.D.

“RepliCel’s RCT-01 addresses a serious and chronic disease of the tendon caused by a cycle of injury, healing and re-injury which results in frequent periods of pain and limited function,” stated David Hall, CEO of RepliCel. “Efficacy and safety results from initial studies led by Dr. Connell form the basis for our current plan to conduct a large efficacy trial beginning with Achilles tendinosis. We are delighted to have these key opinion leaders join with RepliCel to guide the development of our promising treatment for chronic tendinosis.”

“Regenerative cell therapy using RepliCel’s approach addresses the inherent cellular deficit of active fibroblasts seen in chronic tendinosis and represents a significant step forward,” said Ross G. Davidson, MBChB, Clinical Advisory Board Chairman. “RCT-01’s autologous hair follicle-derived fibroblast cells express significantly more Type I collagen than adipose derived fibroblasts, which should make this an ideal candidate to restore function for those patients suffering from chronic tendinosis.”

“My original clinical work on Achilles, patellar and elbow tendinopathies demonstrated the clinical promise of addressing the cellular deficit of active fibroblasts in chronic tendinosis, the cells necessary to complete the healing cycle,” stated David A. Connell, MBBS. “RepliCel has isolated a source of fibroblasts which produce higher levels of Type I collagen than the adipose derived fibroblasts which I used in my human proof of concept trials. RCT-01 has the potential to become the standard of care in chronic tendinosis.”

“Chronic tendinosis is not only an increasing problem in sports medicine, but also in everyday life as our aging populations get more active,” stated Jack E. Taunton, M.D. “The successful direct stimulation of resident fibroblasts has eluded clinicians, but RepliCel’s approach addresses this issue by injecting a patient’s own fibroblasts directly into the damaged tendon. This approach holds tremendous promise as a therapy in tendonopathy.”

The background for each appointed member of the Clinical Advisory Board is as follows:

Ross G. Davidson, MBChB, Chairman
Dr. Davidson has facilitated the recovery of numerous high profile professional athletes during his 30 year career in sports medicine. He is currently a member of the New Zealand Orthopaedic Association and the Canadian Orthopaedic Association. He is the past president of the National Hockey League Physicians Society, past head physician and orthopaedic consultant for the Vancouver Canucks Hockey Club (NHL), past orthopaedic consultant to the Vancouver Grizzlies Basketball Team (NBA), and past orthopaedic consultant to the Canadian Football League Players Association. Dr. Davidson held the position of clinical professor, department of orthopaedics at the University of British Columbia until 2000 and currently has appointments to the Auckland Surgical Centre and Southern Cross Hospital in New Zealand. He is also the Director of the Post-Graduate Programme in Sports Medicine at the University of Auckland. Dr. Davidson is a highly regarded and sought-after lecturer and is published in 17 scientific publications on sports-related injuries and treatments.

Jack E. Taunton, M.D.
Dr. Jack Taunton serves as Professor in the Faculty of Medicine, Division of Sports Medicine at the University of British Columbia and has a clinical practice in sports medicine at the Allan McGavin Sports Medicine Centre where he was the director for over 25 years after co-founding the centre in 1979. Thirty years ago, he co-founded Sportmed BC while president of the Sports Medicine Council of Canada. Dr. Taunton is also currently the director of Sports Medicine for Fortius Sport and Health and is on the board of directors of the Canadian Centre for Ethics in Sport. He served as the Chief Medical Officer (CMO) for the Vancouver 2010 Olympic and Paralympic Winter Games and CMO for Canada at the Sydney Olympics, two Pan American and two World Student Games. He was the Women’s Team Physician and Association Coordinating Physician for Field Hockey Canada for over 25 years. Dr. Taunton was the Team Physician for the Vancouver Grizzlies NBA team during its time in Vancouver. He was co-founder of the Vancouver Marathon, the Vancouver Sun Run and most recently the UBC Grand Prix of Cycling. He was inducted into the BC Athletics Sports Hall of Fame and the Burnaby Sports Hall of Fame and was named to the Globe and Mail 2012 Power 50. In 2012, he was the recipient of the Queen’s Diamond Jubilee Medal.

David A. Connell, MBBS
Dr. Connell is a recognized international authority on muscle and tendon injuries. His private practice is dedicated to musculoskeletal radiology and he serves as an associate professor in the Faculty of Medicine at Monash University. In 2010, he established a diagnostic and treatment facility for elite athletes in AAMI stadium, Olympic Park in Melbourne. He has authored 91 publications and has spoken at major meetings in 19 different countries. Dr. Connell is the past-president of the Australasian Musculoskeletal Imaging Group, serves on the editorial board of five journals, is an instructor on the Erasmus MRI European diploma, and is an elected fellow to the Faculty of Sports & Exercise Medicine (UK).

About RepliCel Life Sciences
RepliCel is a clinical stage biopharmaceutical company focused on developing autologous cell therapies. RepliCel Hair-01 (RCH-01) is a cellular treatment for androgenetic alopecia (pattern baldness). Shiseido Company, Limited has an exclusive geographic license for RCH-01 in certain Asian countries including Japan, China and South Korea. RepliCel Tendon-01 (RCT-01) is a cell therapy for the treatment of chronic tendon injuries. Both product candidates are based on RepliCel’s innovative technology which utilizes cells isolated from a patient’s own healthy hair follicles to address specific cellular deficits. For additional information please visit www.replicel.com.

Notice Regarding Forward Looking Statements
This press release contains projections and forward-looking statements, as that term is defined under applicable securities laws. Statements in this press release, which are not purely historical, are forward-looking statements that relate to the approval and commercialization of the Company’s hair restoration process, and the Company’s development of its Achilles tendon technology. These statements are only predictions and involve known and unknown risks which may cause actual results and the Company’s plans and objectives to differ materially from those expressed in the forward-looking information, including: negative results from the Company’s clinical trials; the effects of government regulation on the Company’s business; risks associated with the Company’s ability to obtain and protect rights to its intellectual property; risks and uncertainties associated with the Company’s ability to raise additional capital; and other factors beyond the Company’s control. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee future results, levels of activity or performance. Further, any forward-looking statement speaks only as of the date on which such statement is made, and, except as required by applicable law, the Company undertakes no obligation to update any forward-looking statement to reflect events or circumstances after the date on which such statement is made or to reflect the occurrence of unanticipated events. New factors emerge from time to time, and it is not possible for management to predict all of such factors and to assess in advance the impact of such factors on the Company’s business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statement. Readers should consult all of the information set forth herein and should also refer to the risk factor disclosure outlined in the Company’s annual report on Form 20-F for the fiscal year ended December 31, 2012 and other periodic reports filed from time-to-time with the Securities and Exchange Commission on Edgar at www.sec.gov and with the British Columbia Securities Commission on Sedar at www.sedar.com.

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VANCOUVER, BC – April 30, 2013 – RepliCel Life Sciences Inc. (the “Company” or “RepliCel”) (OTCBB: REPCF) (CDNX:RP) is pleased to announce that it is initiating the clinical development of a new autologous cell therapy for the treatment of a variety of chronic tendon injuries including Achilles, patellar and elbow. This technology is based on the Company’s core understanding of the unique biological function of hair follicle cells.

RepliCel´s preclinical research, as well as published clinical Phase I data from its collaborator, Dr. David Connell, indicates that the engraftment of collagen-producing fibroblasts from the dermal sheath of a hair follicle can repair micro-tears and promote the regeneration of damaged tendons associated with chronic tendinosis. Connell’s early Phase I work in humans, using fibroblast cells derived from adipose tissue, produced statistically significant improvements in function and pain. RepliCel is initially planning a Phase II Achilles tendinosis trial that is focused on the same healing pathway developed by Connell; however, a new source of fibroblasts isolated from non-bulbar dermal sheath (NBDS) cells of a hair follicle will be used. This tendon technology, named RepliCel Tendon-01 (RCT-01), will be tested in approximately 90-120 subjects in a Phase II trial anticipated to commence in late 2013. RepliCel’s focus on the use of NBDS cells is based on the fact that these cells produce significantly more type I collagen than fibroblasts derived from adipose tissue. Type I collagen is the primary collagen in tendons.

Rolf Hoffmann, RepliCel’s Chief Medical Officer states, “Dr. Connell was able to demonstrate in three different Phase I trials that direct injection of fibroblasts significantly improves healing in chronic tendinosis. It is our collective hypothesis that the underlying cause of chronic tendinosis is a cellular deficit of collagen producing cells in the injured tendon. RepliCel’s extensive research on the cellular construct and function of hair follicle cells has allowed us to identify and isolate a source of very potent type I collagen producing fibroblast cell population. In Phase I trials, our collaborator achieved statistically significant results (P<0.001) in both function and pain scores for Achilles tendinosis. In studies of patellar and tennis elbow tendinosis, indications of therapeutic benefit, in terms of pain and function, were demonstrated. It is our expectation that our new hair follicle derived fibroblast cell population will provide an improved cell population to further enhance the tendon treatment.”

In parallel to the tendon project, RepliCel continues to develop its cellular treatment for androgenetic alopecia (pattern baldness) named RepliCel Hair-01 (RCH-01). For the past few months RepliCel has been working with regulators to assemble a formal clinical trial application for submission to the Paul-Ehrlich-Institut (PEI), the German competent authority for human clinical trials involving cell therapy. In conjunction, the Company will make a submission to the responsible Ethics Committees. The trial is designed to demonstrate the efficacy and safety of injections of RCH-01 in approximately 120 male participants and will also provide insight into the optimal treatment regimen for hair growth.

David Hall, CEO and President of RepliCel states, “One of the biggest challenges of a biotech company is the development of a pipeline of technologies, especially technologies that are based on your core competency. RepliCel’s tendon repair technology is based on our unique understanding of the cellular function of hair follicle cells and how we could use that knowledge to improve upon a stellar Phase I technology. We are excited to be able to double our Phase II trial activity which adds significant value to the Company.”

About RepliCel Life Sciences
The Company is developing two autologous cell therapies. The first is a cellular treatment for androgenetic alopecia (pattern baldness) named RepliCel Hair-01 (RCH-01). The second is a cell therapy for the treatment of chronic tendon injuries named RepliCel Tendon-01 (RCT-01). Both treatments are based on RepliCel’s innovative technology which utilizes cells isolated from a patient’s own healthy hair follicles to address specific cellular deficits. Phase II clinical trials, for both technologies, are planned for the later part of 2013.

For more information please contact:
Tammey George, Director of Communications
Telephone: 604-248-8696
tg@replicel.com
www.replicel.com

Notice Regarding Forward Looking Statements
This press release contains projections and forward-looking statements, as that term is defined under applicable securities laws. Statements in this press release, which are not purely historical, are forward-looking statements that relate to the approval and commercialization of the Company’s hair restoration process, the Company’s development of its Achilles tendon technology, the expected commencement of the Company’s Phase II clinical trial for its tendon technology, that the Replicel tendon technology will provide therapeutic benefit, in terms of pain and function, for tendonosis, that the new hair follicle derived from fibroblast isolated from NBDS cells will provide improved cell population in the tendon to further enhance tendon treatment, and the expected commencement of the Company’s Phase II clinical trial for its hair restoration technology. These statements are only predictions and involve known and unknown risks which may cause actual results and the Company’s plans and objectives to differ materially from those expressed in the forward-looking information, including: negative results from the Company’s clinical trials; the effects of government regulation on the Company’s business; risks associated with the Company’s ability to obtain and protect rights to its intellectual property; risks and uncertainties associated with the Company’s ability to raise additional capital; and other factors beyond the Company’s control. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee future results, levels of activity or performance. Further, any forward-looking statement speaks only as of the date on which such statement is made, and, except as required by applicable law, the Company undertakes no obligation to update any forward-looking statement to reflect events or circumstances after the date on which such statement is made or to reflect the occurrence of unanticipated events. New factors emerge from time to time, and it is not possible for management to predict all of such factors and to assess in advance the impact of such factors on the Company’s business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statement. Readers should consult all of the information set forth herein and should also refer to the risk factor disclosure outlined in the Company’s annual report on Form 20-F for the fiscal year ended December 31, 2012 and other periodic reports filed from time-to-time with the Securities and Exchange Commission on Edgar at www.sec.gov and with the British Columbia Securities Commission on Sedar at www.sedar.com.

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DISCLAIMER:
The information in these press releases is historical in nature, has not been updated, and is current only to the date indicated in the particular press release. This information may no longer be accurate and therefore you should not rely on the information contained in these press releases. To the extent permitted by law, RepliCel Life Sciences Inc. and its employees, agents and consultants exclude all liability for any loss or damage arising from the use of, or reliance on, any such information, whether or not caused by any negligent act or omission.

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Please note that any opinion, estimates or forecasts made by the authors of these statements are theirs alone and do not represent opinions, forecasts or predictions of RepliCel Life Sciences Inc. or its management. RepliCel Life Sciences Inc. does not, by its reference or distribution of these links imply its endorsement of, or concurrence with, such information, conclusions or recommendations.