Founded December 2017
Stage Technology development
Investor The Trendlines Group
CEO Royi Kaufmann, PhD
SetBone Medical is developing a novel polymer implant to treat vertebral compression fractures (VCFs). The implant, which is placed in the vertebral cavity, is made of porous material that has the mechanical properties of bone.
The soft, solid implant can be easily compressed and delivered in a minimally invasive procedure. A substance is released that converts the soft implant into stiff bonelike material only after correct placement in the cavity.
The market seeks a safe, effective treatment for VCFs.
Managerial and R&D experience developing polymeric-based products; PhD, physical chemistry, Weizmann Institute of Science; MA, biotechnology, Tel Aviv University
Founder and CEO, Inspiro Medical Ltd., acquired by Opko Health Inc.; 15+ years’ medical device and orthopedic implant development; BSc, mechanical engineering, Ben-Gurion University of the Negev
Osteoporosis leads to 1.5 million fractures each year in the United States of which about 750,000 are collapsed vertebra or VCFs. Surgical intervention may be required when bed rest and medical treatment fail to reduce pain.
The two most common minimally invasive techniques to correct VCF are vertebroplasty and kyphoplasty. Both treatment options involve injecting bone cement into the fractured vertebra to stabilize the spine and prevent further deterioration. In kyphoplasty, an inflatable balloon is inserted into the vertebra prior to the injection of bone cement to create a cavity and restore disc height.
Unfortunately, in up to 52% of procedures, there is risk of cement leakage into the spinal canal, blood stream and disc space causing possible paraplegia, embolisms and vertebral fractures (Journal of Medical Case Reports, Feb 2016).
In addition, the curing process (the time it takes for cement to set and harden) is extremely time sensitive. Physicians have about 5-10 minutes to complete the process of mixing the cement and accurately injecting it into the fractured vertebra before the mixture begins to harden.
Worldwide, approximately 20% of people over the age of 70, and 16% of postmenopausal women, suffer from vertebral compression fractures (Journal of Clinical and Diagnostic Research,Ballane, et al., August 2017).
According to GlobalData, the North American kyphoplasty market is expected to increase from $538 million (2016) to ~$1.1 billion by 2023, representing a CAGR of 11.1%.