Healing broken bones with an updated ultrasound device for faster, pain-free and cost-effective healing.
What is the critical gap in cancer treatment that you are addressing?
Just like the kind used in pregnancy exams, ultrasound can accelerate bone fracture healing at an impressive rate of success. In fact, ultrasound is by far the most convenient and effective technology for healing fractures, particularly those stubborn ones that take longer to heal or don’t heal at all. For many people who suffer from cancer or other chronic illnesses delayed bone healing is an unpleasant new normal that can lead to pain, unnecessary surgery, infection or even amputation.
While ultrasound devices for healing bones have been around for over 40 years now (The very first device was approved in 1994.) the technology has not advanced into a cost-effective, first-line treatment. The current FDA approved device on the market uses old techniques and retails at $3,500/unit, which is not reimbursed by insurance. This is a problem for the seven million people in the US who break bones each year, and it is worse for those who are disproportionately affected by delayed healing due to a compromised vasculature system.
An up-to-date ultrasound device for bone healing is long overdue. Acoustic Sciences Associates (ASA) is addressing this. We created a low-intensity pulsed ultrasound device that promises far better outcomes for fracture patients than any existing fracture healing device on the market today. Importantly, our technology can be offered at a significantly lower price than what currently exists ($1000/unit). The ASA device will get patients back on their feet faster, and will dramatically reduce the costs, risks, and pain of undesirable outcomes.
What is the key product development milestone you seek to fund?
ASA has teamed up with ultrasound medical experts from Thomas Jefferson Hospital and Mayo Clinic. Through a blinded study in animal models, our team showed that the ASA device improved bone stiffness (density) and strength by 25% over the current FDA approved device. With these impressive results, the FDA has given us the green light to move forward with clinical testing in patients. To do this, ASA must we develop a “clinical grade” prototype of our device, and run a few safety tests. This will allow us to apply for an FDA “investigational device exemption” to conduct the necessary human clinical trials to get this device in the hands of doctors who can start healing bones with ultrasound.
How will funds be used?
Funds raised from this campaign will be used for the following:
What key resources have/will you acquire to facilitate the accomplishment of the above R&D milestone?
ASA has an excellent relationship with Thomas Jefferson University Hospital, which provided funds in support of initial proof of concept testing. Further, Dr. Levon Nazarian, Professor of Radiology and Vice Chair for Education at Thomas Jefferson University Medical College, is a company advisor and has agreed to serve as Principal Investigator for the proposed clinical study.
ASA is actively raising grant monies to support the FDA clinical trials via a number of NIH grant vehicles designed to further research in the orthopedics space. This includes grant programs run by the National Institute of Biomedical Imaging and Bioengineering (NIBIB) and the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).
Also, ASA has already reached out to medical device companies for whom ASA’s technology represents a good strategic fit, with an eye towards establishing corporate equity sponsorship. ASA will also finally consider dilutive equity funding as an option for clinical trial and commercialization support.
If your technology were to disappear in the “Valley of Death” funding gap, how might this impact society?
If you are one of the seven million Americans who happen to break a bone this year, your likelihood of being healed through ultrasound, a noninvasive, painless, and highly effective treatment, is very small. This is a bigger set back for those with poor bone health due to age, osteoporosis, poor blood circulation and even cancer. If ASA’s ultrasound device does not advance to help those in need, the current status quo for bone healing will remain. We cannot accept this.
An entrepreneur with 15+ years of technical management experience, and a track record of entrepreneurial success. Jason is also a National Intelligence Officer, and the Founder and Chief Technical Officer of Aerstone, one of just five cybersecurity companies in the world certified by the NSA for technical vulnerability assessment.
A well-published and patent-holding biophysicist with 15 years of ultrasonics experience. Robert's specialties are in integrating ultrasonic imaging and therapy. He has served as President of the Ultrasonic Industry Association and is a Fellow of the American Institute of Ultrasound in Medicine.
A well-known and published expert in ultrasound and sonar, with 11 patents in the areas of ultrasound and bone fracture healing. Alan's areas of specialty include acoustical signal processing and acoustic transducer/array design.