Bonus BioGroup
Press Room

Wednesday, 08 August 2018 08:25

Bonus BioGroup Secures Exclusivity in the U.S. over Manufacturing and Commercialization of Live Bone Graft

Rate this item
(1 Vote)

Bonus BioGroup Secures Exclusivity in the U.S. over Manufacturing and Commercialization of Live Bone Graft

logo4footerThe approval of a U.S. Patent grants the Company exclusivity over manufacturing and commercialization of live bone graft. “This is a major achievement for Bonus BioGroup. Our central patent is a strong barrier to entrance, for many long years, to any potential competitor”, says Dr. Shai Meretzki, CEO of Bonus BioGroup. “Exclusivity guarantees Bonus BioGroup’s dominant position in a global bone rehabilitation market, estimated at USD 8 billion per annum”

Haifa, Israel – August 8, 2018 – Bonus BioGroup Ltd. (TASE: BONS.TA), a biotechnology company engaged in developing innovative and unique tissue engineering technology for growing live human bone grafts, for implant in human patients with bone deficiency, today announces that it has received approval from the U.S. Patent Office (USPTO) for a U.S. Patent, granting Bonus Therapeutics, a fully owned subsidiary of the Company, protection of exclusivity over the use and commercialization of live bone grafts.


To the best of the Company’s knowledge, the Approved U.S. Patent precludes potential direct competitors from manufacturing and selling any type of live bone graft in the U.S. market. Bonus BioGroup’s exclusivity applies to all clinical indications, including, maxillofacial surgery, orthopedic surgery, plastic surgery and any other indication.


“This is a major achievement for Bonus BioGroup. Our central patent is a strong barrier to entrance, for many long years, to any potential competitor”, says Dr. Shai Meretzki, CEO of Bonus BioGroup. “Exclusivity guarantees Bonus BioGroup’s dominant position in a global bone rehabilitation market, estimated at USD 8 billion per annum.”


Dr. Meretzki adds: “Exclusivity also allows Bonus BioGroup the ability to conduct discussion with U.S. regulatory bodies for accelerating the process of approving the Company’s live human bone graft, since the solution is safe, and in some clinical indications has no suitable alternative for treating critical bone deficiency.”


Bonus BioGroup has developed, for the first time ever, an injectable live human bone graft, manufactured at Bonus BioGroup's manufacturing facility in Haifa, under controlled sterile conditions, in a unique environment simulating the conditions necessary for in vivo growth of human bone, within two weeks of sampling the patient's fat tissue.


The global bone rehabilitation market is estimated at approximately USD 8 billion per annum in 2018. Existing alternate solutions for use of an injectable live human bone graft manufactured by Bonus BioGroup are surgery for harvesting bone together with peripheral blood vessels from another part of the patient’s body, and implanting them in the area of the void, or alternatively, using an artificial bone that shall not induce healing and not enable the patient to return to normal activity due to failure of artificial bone to bond with the human body.


About Bonus BioGroup
Bonus BioGroup Ltd. is a biotechnology company listed on the Tel Aviv Stock Exchange, which has successfully completed its first clinical trial Phase I/II for filling bone void in the upper or lower jawbone, through a single injection of live human bone graft manufactured by the Company, to the bone deficiency area. Concurrently to conducting the first clinical trial, Bonus BioGroup has developed a second generation of injectable bone graft, which is more advanced, reduces manufacturing time, with less human involving, at a reduced cost and with suitability for mass production.


Currently, Bonus BioGroup is conducting two clinical trials for its second generation of injectable bone graft, defined as Phase I/II, with the clinical objectives of evaluating safety and efficacy:
1. A second clinical trial began for filling bone void in the upper or lower jawbone, administered by Dr. Ephraim Tzur; commenced in September 2016;
2. A clinical trial began for filling critical bone voids in limbs – arms or legs, administered by Prof. Nimrod Rozen; commenced in August 2017.

Read 4341 times Last modified on Tuesday, 11 December 2018 08:36

FOR MORE INVESTOR RELATION INFORMATION

Press Release, Announcements publication and more

Bonus BioGroup

Image

 

Terms of UsePrivacy Policy        

© 2019 Bonus BioGroup Ltd. All Rights Reserved. Designed By Netron Israel Ltd.