VANCOUVER, British Columbia & SAN RAFAEL, Calif.--(BUSINESS WIRE)--MedCision, LLC, the world leader in next-generation automated cell thawing for advanced therapies, and RepliCel Life Sciences, Inc. (OTCQB: REPCF) (TSXV: RP) (FRA:P6P2) (“RepliCel”), a regenerative medicine company, today announced that RepliCel has joined MedCision’s ThawSTAR® Early Adopter Program, a novel program that helps companies and investigators de-risk thawing of cell therapies in early stage clinical trials through to commercialization and point-of-care. Each participant will receive a ThawSTAR® System on loan that is custom engineered for their unique cell therapy product.
RepliCel Life Sciences intends to adopt ThawSTAR® AT2 Automated Cell Thawing Systems, for thawing of Aseptic Technologies 2.0ml AT-Closed Vials®, into their Phase 2 clinical trial for skin rejuvenation (RCS-01). This NBDS Fibroblast therapy trial will address skin damage caused by aging or UV rays.
The ThawSTAR® System helps eliminate variability prior to therapy administration to a patient by critical control of vial thawing. The first-of-its-kind, digitally enabled, automated instrument was specifically designed to de-risk thawing of live cell therapeutics.
RepliCel’s President and CEO, R. Lee Buckler, commented: “As we get ready to launch our Phase 2 study for RCS-01 injections, we have greater confidence knowing we are using a programmable cell thawing technology. The ThawSTAR technology has been validated in many studies, and I believe that our trial and the industry on a whole will benefit greatly from replacing unstandardized, manual thawing methods with an automated cell thawing system.”
“Clinical trials involving live and dividing cells are far more complex and risky for sponsors and investigators than other types of therapies, and the success or failure of a trial could come down to results being adversely affected by drug handling,” said Rolf Ehrhardt, MD, PhD, Chief Executive Officer of MedCision. “All of the execution, effort, and money that goes into production of the therapy can be undone with errors in the last step prior to administration: thawing. Our ThawSTAR System is designed to avoid these problems. We are delighted to support RepliCel Life Sciences, an innovative regenerative medicine company, in their trials.”
For more information about the program, visit https://www.medcision.com/resources/thawstar-clinical-early-adopter-program/.
About RepliCel Life Sciences
RepliCel is a regenerative medicine company focused on developing autologous cell therapies that address conditions caused by a deficit of healthy cells required for normal tissue healing and function. The Company’s product pipeline is comprised of three clinical-stage products: RCT-01 for tendon repair, RCS-01 for skin rejuvenation and RCH-01 for hair restoration. RCH-01 is under exclusive license by Shiseido Company for certain Asian countries. All product candidates are based on RepliCel’s innovative technology, utilizing cell populations isolated from a patient’s healthy hair follicles.
RepliCel is also developing a proprietary injection device (RCI-02) optimized for the administration of its products and licensable for use with other dermatology applications. Please visit http://replicel.com/ for additional information.
MedCision is the world leader in next-generation automated cell thawing for advanced therapies. The company develops and commercializes technologies that automate and standardize the clinical handling and processing of biologics. MedCision's digitally enabled ThawSTAR® Automated Cell Thawing Systems are designed to replace uncontrolled and highly variable manual methods, de-risking the therapeutic cell thawing process and optimizing cell efficacy. An industry first, ThawSTAR systems optimize cell thawing using a customizable algorithm for each unique cell therapy product and protocol. These systems, combined with MedCision’s ultra-low temperature cold storage and transport solutions, advance near-patient drug management by providing controlled and scalable processing of temperature-sensitive biotherapeutic products. For more information please visit www.medcision.com or www.medcision.com/blog/.
Certain statements in this news release are forward-looking statements, which reflect the expectations of management regarding the results of the UBC project outlined in this release. Forward-looking statements consist of statements that are not purely historical, including any statements regarding beliefs, plans, expectations or intentions regarding the future. Forward looking statements in this news release include: statements relating to the statements that (i) data from this project is expected to take RepliCel’s products to next level of potential commercial viability; (ii) the gene and protein expression map will improve key components of the manufacturing, regulatory, and clinical profile of RepliCel’s cell therapy products; and (iii) the results will improve our product manufacturing, clinical outcomes, and assays critical to regulatory approval and commercialization. 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 statements, including: the risk that there will be delays enrolling clinical trial participants; the risk that the Company will receive negative results from the Company’s clinical trials; the effects of government regulation on the Company’s business; risks associated with future approvals for clinical trials; risks associated with the Company obtaining approval for its clinical trial in Germany; risks associated with the Company obtaining all necessary regulatory approvals for its various programs in Canada, the USA and Germany; risks associated with the Company’s ability to obtain and protect rights to its intellectual property; risks and uncertainties in connection with the outstanding issues alleged by Shiseido in connection with the License and Co-development Agreement; 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, 2016 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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