Founded December 2017
Stage Technology development
Investor Trendlines Incubators Israel
CEO Royi Kaufmann, PhD
SetBone Medical’s novel soft, solid implant can be easily compressed and delivered in a minimally invasive procedure.
SetBone Medical is developing a novel acrylic-based bone augmentation cement for use in kyphoplasty procedures. The Company’s unique cement overcomes the drawbacks of current liquid acrylic cements, including on-site preparation, limited time for filling, and cement leakage.
The SetBone cement exists in two solid phases. In its initial phase, the material is soft, yet solid, and can be safely inserted during a minimally invasive procedure and pressed to fill the entire vertebral cavity. After exposure of the implanted bone cement to body temperature, it transforms to its final phase, a stiff, stable material. The procedure is similar to existing kyphoplasty procedures and uses the same access tools.
SetBone cement will come in ready-to-use, pre-filled bone fillers, packed in a sterile blister tray. No preparation required.
Filed PCT and submitting National phase
The market seeks a novel cement that overcomes the drawbacks of current liquid acrylic cements for the treatment of vertebral compression fractures (VCFs). Osteoporosis leads to 1.5 million fractures each year in the United States, of which 750,000 are vertebral compression fractures (VCFs).
According to Global Data, 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%.)
• Working prototype
• Tested on cadaver
• No leakage (common with bone cement injection)
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
Expert in spinal neurosurgery; Deputy Director, Center for Spine Surgery, Assuta Medical Center, Tel Aviv; MD, Hebrew University of Jerusalem; former practice in neurosurgery of spine, Montefiore Medical Center, New York
Osteoporosis leads to 1.5 million fractures each year in the United States of which about 750,000 are collapsed vertebra or vertebral compression fractures (VCFs). Surgical intervention may be required when bed rest and medical treatment fail to reduce pain.
The two most common minimally invasive procedures 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.
In the United States, more than 100,000 VCFs are treated with vertebroplasty and kyphoplasty. Unfortunately, in up to 52% of procedures, there is risk of cement leakage into the spinal canal, bloodstream, 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 MeddeviceTracker, the worldwide kyphoplasty systems market is estimated at $700 million expected to reach $850 million by 2023; in addition to sales from vertebroplasty products of approximately $160 million.
