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Wednesday, 22 January 2020 06:18

Confirmation of issued patent in Europe, which in concert with the issued patents in the USA and Australia, provides Bonus BioGroup the exclusive rights for the commercialization in 70% of the world population with a high income profile1, in a world

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Bonus BioGroup is pleased to announce the approval of the European patent by the European Patent Office (EPO), which provides Bonus Therapeutics, a subsidiary of Bonus BioGroup, exclusive protection for the development, utilization and commercialization of Bonus’ live bone graft product in Europe, for the treatment of bone deficiencies (hereafter: “the European patent”), applied by injection or by any other manner.

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The company’s rights in the technology protected by this patent and in combination with other patented technologies as well as patent applications (all together hereafter: “the patents’), may grant Bonus exclusivity for the final product as well as for its developmental stages, manufacturing and growth of the bone graft, including the application of various cell types for the generation of the bone graft outside the human body, and its final composition in the specialized delivery and mixing syringe.

To the company’s better knowledge, it is not feasible to generate a live bone graft from a single cell type, and several cell types are necessary to produce any live bone graft, the patents may prevent competitors not only from manufacturing and marketing a bone graft which is similar to Bonus’s product, but also from manufacturing and marketing of a live bone graft of any kind.

In the previous week, Bonus BioGroup announced an investment agreement constituting consideration of NIS 25.6 million in cash, in exchange for ordinary shares for NIS 0.50 per share. As of the time of this current report, the company has raised a total capital of about NIS 109.5 million in cash (approximately USD 31.7 million), of which Bonus has raise about NIS 88 million in cash (approximately USD 25.5 million) in private agreements representing an average of 17% premium above share price at market closure preceding the relevant agreements.

Prior to the approved European patent, grafting exclusivity until April 7, 2029, Bonus was granted with the approval from the US Patent and Trademark Office (USPTO) for a patent in the USA8, which grants exclusivity until February 12, 2030, as well as the approval of the Australian Patent Office (WIPO) for a patent in Australia9, granting exclusivity until April 8, 2035.
The Company’s rights in this patented technology and in other patented technologies, may grant Bonus with an exclusive marketing of live bone grafts for about 850 million people, which are about 70% of the 1.2 billion world population from a high-income country, as defined by the world bank10.

Protection over the exclusivity for the development, utilization and marketing of Bonus BioGroup’s injectable, live bone graft, are granted by the various patents over the entire bone graft market, in all medical indications, including oral and maxillofacial surgery, orthopedic surgery, plastic surgery, and any other relevant indications.

The current principal standard of care treatment option is autograft, which entails a major surgery for the harvesting of healthy bone, including peripheral blood vessels in some cases, from the patient and its implantation at the bone defect site. Alternative treatment options include bone graft substitutes, which are significantly inferior to autograft and treatment results are often insufficient and unsatisfactory, mostly due to the deficient natural connection of the bone substitute with the patient’s bone.

Bonus BioGroup’s injectable live bone graft is grown outside the human body in the company’s manufacturing facility, and is based on the patient’s own cells, originating from the patient’s adipose tissue. The utilization of the patient’s own cells significantly diminishes the danger of immunological reactions that can lead to graft rejection, which is a common risk in treatments performed with cells or tissue from other human donors (Allograft). Furthermore, the manufacturing of Bonus’ bone graft requires the patient’s adipose tissue to be harvested by the relatively simple procedure of liposuction, thus not requiring a major surgical procedure, and accordingly may alleviate the healthcare system as well as facilitate the patient’s recovery. The second-generation of the injectable, live bone graft, is more advanced, manufactured in a shorter time period, with fewer human handling, at reduced costs, and particularly adapted for mass production.

Bonus BioGroup aims to offer the bone regeneration market, which worldwide is estimated at USD 8 billion per year, in 2020 a safe and efficient treatment for bone deficiencies, that entails a single procedure for the injection of the graft material, generated from the patient’s own cells, into the bone defect site.
Bonus BioGroup currently holds the exclusive rights for six patent families and patent applications, which consists of 14 approved patents and 18 outstanding patent applications. Patent protection is generally granted for a period of 20 years, from the filing date of the application.

Bonus BioGroup is continuously filing patent applications with the goal to realize a worldwide breakthrough in safe and efficient bone repair for various indications, with an injectable bone graft material requiring a single treatment, as was demonstrated in the company’s first clinical trial in the indication of bone regeneration in the upper and lower jaw bones, in which all trial participant’s were successfully treated, without differentiations in gender, age, and medical history. The trial results established a safety and efficiency profile of Bonus’ bone graft product which is a rarity in any other medical treatment.
Currently, there are two ongoing phase I/II clinical trials for the evaluation of the second-generation bone graft product’s safety and efficacy in two indications:
  1. A clinical trial for the treatment of upper and lower jaw bone deficiencies, initiated in September 2016 and supervised by Dr. Ephraim Tzur, DMD.
  2. A clinical trial for the treatment of long bones deficiencies – arm or leg, initiated in August 2017 and supervised by Prof. Nimrod Rozen, MD, PhD.

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