CYTX Cytori Therapeutics Inc

Cytori Therapeutics, Inc. (NASDAQ:CYTX) announced today that the American Medical Association’s (AMA) CPT® (Current Procedural Terminology) Editorial Panel has approved the company’s request to add two new Category III CPT codes that describe a cell-based therapy for patients with scleroderma of the hands. These codes have been published on the AMA website and will be effective January 1, 2018.

The AMA’s CPT® Editorial Panel creates Category III CPT codes to describe new and emerging healthcare technology, services, and procedures.  Cytori worked with the American College of Rheumatology, the American Society of Plastic Surgeons, and the American Society for Surgery of the Hand to prepare the requests and received approval for the following Category III CPT codes:

• 0489T, for autologous adipose-derived regenerative cell (ADRC) therapy for scleroderma in the hands; adipose tissue harvesting, isolation and preparation of harvested cells including incubation with cell dissociation enzymes, removal of non-viable cells and debris, determination of concentration and dilution of regenerative cells
• 0490T, for autologous ADRC therapy for scleroderma in the hands; multiple injections in one or both hands

“We applaud the Editorial Panel’s approval of these two new CPT codes, as it marks the essential first step in enabling physician and facility access to our investigational Habeo™ Cell Therapy in the U.S.,” said Russ Havranek, Vice President, Global Marketing at Cytori. “We are also thankful for the support provided by the medical specialty societies in helping us achieve this important milestone.” 

Cytori is currently conducting the U.S. Phase III pivotal STAR trial, a randomized, double-blind, placebo-controlled, parallel-group, multi-center study investigating the safety and efficacy of Habeo™ Cell Therapy in patients with hand dysfunction due to scleroderma. STAR follows the 12-patient SCLERADEC-I trial, an open-label, single-arm, investigator-initiated study conducted in Marseille, France.  More information about STAR and SCLERADEC-I can be found on clinicaltrials.gov and sciencedirect.com, respectively.

“Scleroderma with hand dysfunction is an extremely debilitating disease, and yet patients historically have had very limited treatment options,” said Dinesh Khanna, M.D., M.S., the Frederick G.L. Huetwell Professor of Rheumatology, Professor of Internal Medicine, and Director of the Scleroderma Program at the University of Michigan, and principal investigator in the Phase III STAR trial of Habeo™ Cell Therapy in patients with hand dysfunction due to scleroderma. “Habeo™ Cell Therapy is a novel treatment with the potential to make a significant impact in these patients’ lives.  I am encouraged by the clinical evidence generated to date and look forward to reviewing the STAR 48-week results.”

“The codes approved by the Panel accurately describe Habeo™ Cell Therapy,” said STAR investigator Mark Granick, M.D., Professor of Surgery and Chief of Plastic Surgery in the Department of Surgery at Rutgers New Jersey Medical School. “The use of ADRCs for treating scleroderma related hand dysfunction requires far more specificity and effort than the more commonly performed liposuction or fat grafting procedures.  The injection of the ADRC solution into the fingers similarly is a highly specialized process requiring a familiarity with hand anatomy and surgery.”

About Scleroderma Scleroderma is a rare and chronic connective tissue disease generally classified as an autoimmune rheumatic disorder. The word “scleroderma” is derived from two Greek words: “sclera,” which means hard, and “derma,” meaning skin, as hardening of the skin is one of the most visible manifestations of the disease. An estimated 300,000 Americans have scleroderma, about one-third of whom have the systemic form of the disease (also known as systemic sclerosis, or SSc), which affects the skin, subcutaneous tissues, blood vessels, and major organs.2

The hand manifestations of scleroderma, which result from vascular disease (ischemia, or lack of blood supply to a body part) and fibrosis (scarring), are extremely common and lead to functional impairment and diminished quality of life. Hand involvement may present as digital ulcers (skin breakdown at or near the fingertip, resulting in painful ulcers that are difficult to heal), Raynaud's phenomenon (RP, skin discoloration resulting from narrowing of the blood vessels in response to cold, emotional upset, or stress), calcinosis (calcium deposits in the soft tissues of the hand), swelling or puffiness of the hands, joint pain and stiffness, and sclerodactyly, which literally means “hard skin of the digits,” and is characterized by shiny, tight skin on the fingers.  RP affects more than 90% of patients with SSc, and may precede SSc by months or even years. 1,2

The initial treatment approach for RP is to keep digits clean and protect them from the cold. Although physicians may use various types of medications, such as calcium channel blockers, intravenous prostacyclin, and non-selective endothelin receptor antagonists, to treat the hand manifestations of scleroderma, these agents are costly, have very limited benefit, require close monitoring, and may trigger substantial adverse events. Consequently, there is a distinct medical for a safe and effective therapy to address scleroderma-related hand dysfunction.1

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™, investigational in the U.S., 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.

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 timing of the Habeo™ Cell Therapy Early 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 our Cytori’s Habeo™ Cell Therapy product; risks in the collection and results of clinical data; risks associated with development of our 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.

1 http://www.scleroderma.org 

2 https://www.niams.nih.gov/health_info/scleroderma/scleroderma_ff.asp#b  

Cytori Therapeutics, Inc.

Tiago Girao, 1-858-458-0900

ir@cytori.com