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RegenScientific and Boston Medical Products enter into US distribution agreement

Vocal Fold Injectable Implant

Vocal Fold Injectable Implant

The companies will collaborate in the sales and marketing efforts of Renú® Gel and Renú® Voice to otolaryngologists and hospitals in the United States

EAST TROY, WISCONSIN, USA, June 7, 2016 /EINPresswire.com/ -- East Troy, Wisconsin and Shrewsbury, Massachusetts, June 8, 2016 /EIN News/ -- RegenScientific and Boston Medical Products announced today that the companies have entered into a distribution agreement for Renú® Gel and Renú® Voice in the United States.

RegenScientific launched these injectable implants in the United States last year after receiving FDA-clearance for vocal fold insufficiency which is a condition often found in patients with voice and swallowing disorders. Boston Medical Products manufactures and distributes medical devices to otolaryngologists (ear, nose and throat doctors) and speech-language pathologists - the company’s products includes the well-know and successful Montgomery® Thyroplasty Implant System intended for surgical treatment of severe voice disorders.

“We are excited to collaborate with Boston Medical Products to expand the availability of our cost-effective vocal fold injection augmentation products to physicians treating patients with certain voice disorders,” said Mr. Charles Milo, MBA, Chief Business Officer at RegenScientific, and he continued, “Boston Medical Products is a company with a long history of providing quality products to otolaryngologists and we’re pleased that our products are now part of their product offering.”

Mr. Stuart Montgomery, MBA, President of Boston Medical Products said, “Our Montgomery® Thyroplasty Implant System has over 18 years of clinical and commercial success in the United States and around the world, and by adding Renú® Gel and Renú® Voice, which are injectable implant solutions for certain patients, we will expand treatment options for otolaryngologists and their patients.”

“Over the next few months we will integrate Renú® Gel and Renú® Voice into our United States sales organization,” said Thomas Gusha, Sales Manager at Boston Medical Products, and he continued, “and we will direct considerable marketing efforts to inform otolaryngologists of the availability of these products from our company.”

Boston Medical Products will exhibit Renú® Gel and Renú® Voice, and their existing product line at these upcoming trade shows: American Head and Neck Society in Seattle, Washington, July 16-20, 2016; American Academy of Otolaryngology - Head and Neck Surgery in San Diego, California, September 18-21, 2016, and the Fall Voice Conference, Scottsdale, Arizona, October 13-15, 2016; as well as other events directed at otolaryngologists and speech-language pathologists.

RegenScientific will continue to sell Renú® Gel and Renú® Voice directly to otolaryngologists and hospitals in the United States for a limited time, and the company is actively seeking distributors in Europe, South America, and Asia-Pacific for both the otolaryngology and dermal filler indications.

Renú® is not yet FDA approved as a dermal filler in the United States but RegenScientific has filed an Investigational Device Exemption (IDE) with the FDA, and is currently identifying the Principal Investigator and investigational sites for the study. The company plans to start a clinical study of Renú® in the United States to gain FDA approval as a dermal filler.

About RegenScientific:

RegenScientific, a wholly-owned business unit of Cytophil, Inc., an ISO 13485 certified company, is dedicated to providing physicians and patients with high-quality, safe, efficacious, and cost-effective tissue augmentation implants. The company has CE-Mark for its Renú® Soft Tissue Volumizing Implant for Lipoatrophy, Vocal Fold Insufficiency and Soft Tissue Augmentation in Europe. The Company has FDA 510k clearances for its Renú® Gel and Renú® Voice otolaryngology products indicated for vocal fold injection augmentation. RegenOsteo™ (β-TCP), its orthopedic surgery product is indicated to fill bony voids or gaps in the extremities, posteriolateral spine and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure. RegenPerio™ (β-TCP), its maxillofacial surgery product is indicated for use as a bone grafting material to fill, augment, or reconstruct periodontal or oral-maxillofacial defects.

Renú® is a registered trademark of Cytophil, Inc. REGENSCIENTIFIC™ and the REGENSCIENTIFIC logo, RegenOsteo™ and RegenPerio™ are trademarks of Cytophil, Inc.

Contact RegenScientific:

Charles F. Milo, MBA
Chief Business Officer
Tel: (262) 215-6779
Email: cmilo@cytophil.com

About Boston Medical Products, Inc.:

Founded in 1980, Boston Medical Products was created by three practicing otolaryngologists to provide the medical community with unique and innovative products for use in airway management. Working closely with surgeons, other healthcare providers and patients themselves, Boston Medical Products has grown and evolved into an internationally respected medical device manufacturing and distribution company. We continue our research and development program to initiate leading-edge products in the areas of ENT surgery, Respiratory Therapy, and Thoracic Surgery, welcoming all inquiries and suggestions for the improvement of existing products, as well as new product ideas. Strong partnerships with our medical colleagues continue to be of great importance to us.Montgomery® is a registered trademark of Boston Medical Products, Inc.

Contact Boston Medical Products, Inc.:

Thomas V. Gusha 
Manager, U.S. Sales

Tel: (508) 898-9300, ext. 203

Email: tgusha@bosmed.com

Charles Milo
RegenScientific - Cytophil, Inc.
262-215-6779
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