“Providing compliant access to patients who may benefit from therapies in clinical development is the objective of Managed Access Programs (MAP). Habeo Cell Therapy fits the defined parameters of a MAP-eligible therapy. Towards that end, Cytori is excited to leverage myTomorrow’s expertise and expanded scope to take our MAP in a new direction,” said John Harris, Vice President and General Manager at Cytori. “We look forward to kicking off our relationship at the EULAR congress in Madrid, Spain this week.”
myTomorrows is an innovative and fully integrated organization dedicated to providing fully compliant early access to innovative therapeutics in advance of the products full marketing authorization in the countries that it serves. myTomorrows will serve as Cytori’s exclusive MAP for patients with scleroderma-associated hand dysfunction. myTomorrows will leverage its footprint to provide patients early access to Habeo Cell Therapy for the Middle East and Latin America in addition to Europe.
“The opportunity to collaborate with Cytori to lend support to patients in need is exactly in line with our team’s mission and core competences,” said Govert Schouten, Co-Founder and Chief Business Officer at myTomorrows.
The EULAR Congress is considered to be a major event in the global rheumatology network and seeks to serve as a platform to facilitate interactions between patients, medical doctors, scientists, health professionals and industry surrounding scientific and clinical information. Cytori Therapeutics’ booth is #47 in the main congress hall, where we will highlight the STAR and SCLERADEC-II clinical trials that are currently in progress in the U.S. and France, respectively. Representatives will be available to answer questions about the Habeo Cell Therapy Managed Access Program.
myTomorrows will be responsible for the design, implementation, and performance of the Managed Access Program and their Netherlands-headquartered and field-based teams will apply their knowledge and expertise toward physician and patient support, legal and regulatory administration, pharmacovigilance, logistics, and data collection.
About Cytori Therapeutics
Cytori is a therapeutics company developing regenerative and oncologic therapies from its proprietary cell therapy and nanoparticle platforms for a variety of medical conditions. Data from preclinical studies and clinical trials suggest that Cytori Cell Therapy™ acts principally by improving blood flow, modulating the immune system, and facilitating wound repair. As a result, Cytori Cell Therapy™ may provide benefits across multiple disease states and can be made available to the physician and patient at the point-of-care through Cytori’s proprietary technologies and products. Cytori Nanomedicine™ is developing liposome encapsulated therapies for regenerative medicine and oncologic indications. For more information, please visit www.cytori.com.
myTomorrows provides information about treatment options and facilitates access to pre-approval medicines for physicians and their patients with unmet medical needs. myTomorrows supports these activities via its data-infused digital marketplace that combines actionable and uniform public information about Early Access Programs and Clinical Trials. To learn more, please visit: www.mytomorrows.com.
Cautionary Statement Regarding Forward-Looking Statements
This press release includes forward-looking statements regarding events, trends and business prospects, which may affect our future operating results and financial position. Such statements, including, but not limited to, statements regarding availability and implementation of the Habeo Cell Therapy Managed Access Program are subject to risks and uncertainties that could cause our actual results and financial position to differ materially. Some of these risks and uncertainties include: risks in development, manufacture and commercial launch of Cytori’s Habeo Cell Therapy product; risks in the conduct of clinical trials, including STAR and SCLERADEC-II; risks associated with potential benefits of Cytori’s Habeo Cell Therapy product; risks in the collection and results of clinical data; risks associated with development of Cytori’s clinical pipeline; final clinical outcomes; regulatory risks and uncertainties; risks related to dependence on third party performance; and other risks and uncertainties described under the “Risk Factors” section in Cytori’s Securities and Exchange Commission Filings on Form 10-K and Form 10-Q. Cytori assumes no responsibility to update or revise any forward-looking statements contained in this press release to reflect events, trends or circumstances after the date of this communication.