Tag Archives: BioTissue

Bio-Tissue Announces First Study to Demonstrate Corneal Nerve Regeneration in Patients with Dry Eye Disease with the Use of PROKERA

Company’s Proprietary Cryopreserved Amniotic Membrane Continues to Advance Treatment of the Ocular Surface

MIAMI, November 9, 2017 – Bio-Tissue, Inc., a business unit of TissueTech, Inc., announced today the publication of “Corneal Nerve Regeneration after Self-Retained Cryopreserved Amniotic Membrane in Dry Eye Disease” in The Journal of Ophthalmology, 2017 (John, et al.), the first study to show that cryopreserved amniotic membrane is correlated with corneal nerve regeneration in patients with dry eye disease (DED). The study results will be presented at the upcoming American Academy of Ophthalmology (AAO) meeting taking place November 11 – 14, 2017 in New Orleans.

In this prospective, randomized controlled clinical trial conducted at the Thomas John Vision Institute, 20 patients with DED were randomly treated with cryopreserved amniotic membrane (PROKERA), or conventional maximum treatment (control). PROKERA was found to be a promising therapy for corneal nerve regeneration and to accelerate the recovery of ocular surface health in patients with moderate and severe DED.

In the clinical trial, patients who completed the one-month and three-month study with cryopreserved amniotic membrane (PROKERA) showed significant improvement in their DEWS score, pain score, TFBUT, fluorescein staining, and SPEED score. Further, these patients exhibited a significant increase in central corneal nerve density both at the one-month and three-month periods, and significant improved corneal sensation from a baseline of 3.25 ± 0.6 cm to 5.2 ± 0.5 cm at one-month and 5.6 ± 0.4 cm at three-months. There was also improved corneal surface topography in terms of wavefront aberrations as well as the cylinder that is induced in dry eye patients. These results were confirmed by a masked reader at Tufts Medical Center in Boston.

“These findings are quite significant as this is the first study to demonstrate that cryopreserved amniotic membrane is correlated with corneal nerve regeneration, as evidenced by an increase in corneal nerve density and improved corneal sensitivity,” said Thomas John, MD, Thomas John Vision Institute and co-principal investigator of the clinical trial. “Prior to this study, no therapeutic modality was shown to regenerate corneal nerves, which play a key role in tear film stability and ocular surface health. Consistent with our findings, cryopreserved amniotic membrane controls inflammation and promotes healing and nerve regeneration.”

PROKERA is a sutureless, FDA-cleared Type II medical device that is used in office by eye doctors around the world to treat corneal involved dry eye and other ocular surface diseases. PROKERA is manufactured using Bio-Tissue’s proprietary CryoTek® technology, which has been proven to preserve the innate biological and structural properties of the amniotic membrane matrix. The components of this matrix have been demonstrated to support regenerative healing in the eye.

“Unlike competitive products preserved via dehydration, PROKERA has been shown to be clinically effective in patients with dry eye disease and other ocular surface diseases, due to the extracellular matrix components, including HC-HA/PTX3, which have been shown to orchestrate regenerative healing,” said Scheffer C.G. Tseng, MD, PhD, Chief Technology Officer, TissueTech. “This study is further evidence of the clinical efficacy of cryopreserved amniotic membrane through the use of PROKERA, and specifically its ability to regenerate corneal nerves and accelerate healing of the ocular surface in patients with dry eye disease.”

About Bio-Tissue
Bio-Tissue (www.biotissue.com), a business unit of TissueTech, Inc., develops and markets regenerative therapies that allow eye care professionals to advance the standard of care for treating the ocular surface. Its core products include cryopreserved amniotic membrane and umbilical cord-based tissue with innate therapeutic actions scientifically proven to heal the ocular surface. The Company’s proprietary CryoTek preservation method ensures the tissue retains its biologic activity and healing components. To date, more than 300,000 allografts have been transplanted collectively by Bio-Tissue and sister company Amniox Medical, Inc.

MEDIA CONTACT:

Silvana Guerci-Lena
Bio-Tissue
(508) 808-8993, sguercilena@biotissue.com

TissueTech Inc. Awarded Four Patents for Proprietary Technology to Use Placental Tissue for Regenerative Medicine

Company has more than 40 issued patents

MIAMI – September 14, 2017 – TissueTech Inc. announced today that it has been awarded four patents by the U.S. Patent Trademark Office. Two of the patents cover methods of promoting bone formation and the others cover methods for lyophilizing and sterilizing placental tissue.

“TissueTech continues to maintain its status as the leader in the scientific understanding and innovative application of placental tissue in regenerative medicine,” said Amy Tseng, Chief Executive Officer of TissueTech. “In addition to being the recipient of four new patents, the company recently surpassed the milestone of 300,000 human implants performed by clinicians and our research is backed by more than 30 years of continuous funding through the National Institute of Health. The recognition of this technology and its use in medicine underscores our success in finding new and important arenas where regenerative therapy offers the potential to address underserved and unmet clinical needs and improve patients’ lives.”

The four patents issued to TissueTech apply to:

  • The use of placental tissue in different forms to address the typical effects of bone diseases including arthritis, osteoporosis, bone tumors, Paget’s Disease, and alveolar bone degradation.
  • A method of promoting or inducing osteogenesis in an individual in need thereof, comprising contacting a bone or joint in the individual with a therapeutically-effective amount of placental tissue.
  • The preservation and sterilization of placental tissue necessary to make it available to physicians for transplantation to patients in clinical need.
  • A method of preparing a placental tissue powder product by lyophilizing placental tissue and grinding the lyophilized tissue to generate a product that can be delivered less invasively.

”TissueTech was the first company to introduce cryopreserved umbilical cord and amniotic membrane tissues for clinical transplantation,” said Scheffer Tseng, MD, Ph.D., Chief Technology Officer of TissueTech. “As a pioneer in this space and with the continued support of our NIH grant and the private capital that we have raised, we will continue to lead in the development of innovative technologies and delivery techniques to better serve patients across all sectors of healthcare with regenerative therapy options.”

Numerous disease states are the direct result of damage to normal tissue and the associated inflammation, along with the body’s consequent inability to restore a normal state of function. Research has demonstrated that regenerative healing occurs in the fetal environment due to the inherent ability of the placental tissues, particularly the umbilical cord and amniotic membrane, to modulate inflammation and create an environment that is conducive to healing. More importantly, these properties can be preserved and transplanted to other environments to facilitate the improved outcomes following surgical procedures or even the closure of chronic, hard-to-heal wounds.

About TissueTech, Inc.

TissueTech, Inc., the parent company of Amniox Medical and Bio-Tissue, Inc., pioneered the development and clinical application of regenerative, amniotic tissue-based products. Amniox Medical markets products for use in the musculoskeletal and wound care markets; Bio-Tissue markets products for the ophthalmology and optometry markets. The National Institutes of Health (NIH) has supported TissueTech’s research with more than 30 continuous years of research grants. Since the company’s inception, clinicians have performed more than 300,000 human implants of the company’s products and published more than 300 peer-reviewed studies supporting its technology platform. The company’s first product, AmnioGraft®, is the only tissue graft designated by the FDA as homologous for promoting ophthalmic wound healing while suppressing scarring and inflammation.

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TissueTech, Inc. Names Dr. Herbert B. Slade as Chief Medical Officer

MIAMI – August 1, 2017 – TissueTech, Inc. announced today that Herbert B. Slade, MD, has been named the company’s Chief Medical Officer (CMO). Dr. Slade, who will lead the execution of TissueTech’s clinical research strategies and be the primary liaison for medical affairs, has more than 25 years of healthcare industry-based experience, most recently at Smith & Nephew plc, where he was CMO and Senior Vice President of Research and Development for the wound care division.

Dr. Slade’s previous research background includes prestigious work with Dr. Jonas Salk, who developed one of the first successful polio vaccines. Dr. Salk recruited Dr. Slade from academia to develop an HIV therapeutic vaccine joint venture, where Dr. Slade held the position of Director of AIDS and Immunology at Rhône-Poulenc Rorer.

Dr. Slade later became CMO of 3M Pharmaceuticals for 12 years. Following that appointment, he joined DFB Pharmaceuticals, serving as CMO for Healthpoint Biotherapeutics. After Healthpoint was acquired by Smith & Nephew in 2012, Slade’s role expanded to include their wound care division.

“It is with great enthusiasm that I join the TissueTech executive team. As the first company to commercialize amniotic membrane based technologies for clinical use, it is a pioneer in the field of regenerative medicine,” said Dr. Slade. “The company has an innovative vision for the future development of this platform technology, and I know that my experience in clinical development can be an asset to support the company in achieving those objectives.”

Dr. Slade received his undergraduate degree in biology from Hamilton College and his M.D. from State University of New York Upstate Medical University in Syracuse, New York.

“In addition to being a dual board-certified subspecialist in pediatrics and clinical immunology, Dr. Slade has played pivotal roles in key medical research for a number of reputable companies,” said Amy Tseng, Chief Executive Officer of TissueTech. “As our company continues to grow – we recently achieved the milestone of 300,000 human implants performed by clinicians –an individual with the credentials and knowledge that Dr. Slade provides necessary support for our mission to continue to provide clinicians with advanced regenerative medicine therapies that improve patients’ lives.”

About TissueTech, Inc.

TissueTech, Inc., the parent company of Amniox Medical, Inc. and Bio-Tissue, Inc., pioneered the development and clinical application of regenerative, amniotic tissue-based products. Amniox Medical markets products for use in the musculoskeletal and wound care markets; Bio-Tissue markets products for the ophthalmology and optometry markets. The National Institutes of Health (NIH) has supported TissueTech’s research with more than 30 continuous years of research grants. Since the company’s inception, clinicians have performed more than 300,000 human implants of the company’s products and published more than 300 peer-reviewed studies supporting its technology platform. The company’s first product, AmnioGraft®, is the only tissue graft designated by the FDA as homologous for promoting ophthalmic wound healing while suppressing scarring and inflammation.

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