RANCHO SANTA MARGARITA, Calif.–(BUSINESS WIRE)–Liquidmetal® Technologies, Inc. (OTCQB: LQMT; the “Company”),announced today that it has passed additional pre-screening biocompatibility tests for use in medical implants and is now pursuing collaborations with medical implant companies.

In February of 2017, LQMT received long-term implantation results from parts 3, 10, 6 and 11 of the ISO 10993 (Biological Evaluation of Medical Devices) suite of tests, which include evaluation of genotoxicity, sub-chronic systemic toxicity, and pyrogenicity. LQMT alloy LM105 passed all of these tests well within the allowable limits. These results, combined with previously completed tests from ISO 10993 parts 10, 11, 4, and 5 which cover sensitization, irritation, acute systemic toxicity, hemocompatibility and cytotoxicity, indicate that the Liquidmetal process is compatible with a wide range of medical device requirements including long term implants.

“The results of these tests are very exciting and it positions the Company well to engage medical device customers in a broad range of implantable device applications including, cardiac rhythm, cochlear, spinal, and orthopedic implants among others. The Company will now focus on partnering with medical implant manufacturers to identify specific applications to further explore the use of Liquidmetal,” said Paul Hauck, Executive Vice President of Sales and Marketing at LQMT.

About Liquidmetal Technologies

Rancho Santa Margarita, California-based Liquidmetal Technologies, Inc. is the leading developer of bulk amorphous alloys. Amorphous alloys are unique materials that are distinguished by their ability to be injection molded and die cast into high performance applications for a broad range of markets. For more information, go to www.liquidmetal.com.

BOISE, Idaho–(BUSINESS WIRE)–Burst Biologics has received IRB approval to begin a multicenter prospective clinical study in spinal fusion patients. This study will be conducted using BioBurst Fluid, a cellular allograft derived from umbilical cord blood (UCB) which has shown very promising results in spinal fusion procedures. Fifteen clinical sites will participate throughout the US with a total enrollment of 450 patients.

Popularity of cellular allografts has increased over the last decade. Figures show that the global spine biologics market is valued at $1.6 billion and is expected to reach $2.2 billion by 2022.¹ This represents a significant opportunity for innovative biologic products.

Ira Fedder, MD, Towson, Maryland, explains, “As we continue to try to understand the mechanisms that lead toward successful fusion, it is critical that we consider the cellular content and activity that may contribute to positive outcomes. Patients that have compromised health and/or healing potential may stand to be the biggest benefactors of this type of technology. It is imperative that surgeons demand that companies demonstrate that their products have a positive impact on patient outcomes. A registry is a simple step in that direction.”

As Chris Jones, CEO of Burst Biologics, explains, “An open registry allows us to evaluate success rates in complex cases that would otherwise be excluded from studies. Stringent inclusion-exclusion criteria narrow the patient population and usually involve only single-level procedures, not allowing previous surgery or fusion attempts, and excluding other high-risk conditions. We want to demonstrate to spine surgeons and third-party payers that BioBurst Fluid can be successful in their more challenging patients.”

For more information on this prospective multicenter clinical study, please visit:

www.clinicaltrials.gov

www.burstbiologics.com/fluidclinicaltrial

About Burst Biologics

Burst Biologics is a rapidly growing Biotechnology Company and federally registered tissue bank located in Boise, Idaho. Burst Biologics is a developer of effective tissue processing methodologies, all of which is done at the company’s state-of-the-art research facility. For more information about Burst Biologics or its products, please visit its website at: www.BurstBiologics.com

1. Sandberg, J., Global Spine Biologics Market Expected to Reach $2,214 Million by 2022 – Allied Market Research. OrthoSpineNews, 2017. Available from: https://www.alliedmarketresearch.com/spine-biologics-market.

DURHAM, N.C.–(BUSINESS WIRE)–Bioventus, a global leader in orthobiologics, today announced it will commission an innovative series of real-world evidence, direct-to-patient studies to further validate the ability of its EXOGEN Ultrasound Bone Healing System to mitigate the risk of a fracture progressing to nonunion in the presence of known risk factors. FDA PMA approved in 1994, EXOGEN has provided treatment to more than 1 million patients worldwide for more than 20 years and has a long clinical history. The product uses safe, effective low-intensity pulsed ultrasound (LIPUS) to help stimulate the body’s natural healing process.¹

Recent publications analyzing data from a large registry of almost 8,000 fractures treated with EXOGEN suggest that the device supports healing fractures in patients despite the presence of associated comorbidities or medication use.^2,3,4 This new clinical research, known as the Bioventus Observational Non-interventional EXOGEN Studies (BONES), will build on this evidence and supplement the product’s broad body of clinical knowledge in a prospective population-based innovative clinical development program.

The BONES studies will compare the incidence of fracture nonunions in patients utilizing the EXOGEN device with patients from a national health insurance claims database who received standard of care alone. The studies will include bones representative of long and small bones of upper and lower extremities. The unique design was discussed with FDA during its development.

“BONES represents a significant investment in developing epidemiologically grounded rigorous clinical evidence to support use of EXOGEN in fractures at risk, and to underscore the product’s clinical utility in mitigating the risk of nonunions, a highly debilitating and costly condition,” said Alessandra Pavesio, Senior Vice President and Chief Science Officer, Bioventus. “It will build upon knowledge gained from extensive research conducted by Bioventus and recently published in JAMA Surgery, in over 700,000 fracture patients that has identified 40-plus factors which place a patient at an increased risk of progression to a nonunion.⁵”

About Bioventus

Bioventus is an orthobiologics company that delivers clinically proven, cost-effective products that help people heal quickly and safely. Its mission is to make a difference by helping patients resume and enjoy active lives. Bioventus has two product portfolios for orthobiologics, Bioventus Active Healing Therapies and Bioventus Surgical that make it a global leader in active orthopaedic healing. Its EXOGEN^® Ultrasound Bone Healing System is the #1 prescribed bone healing system in the US and is the only FDA-approved bone healing device that uses safe, effective ultrasound to stimulate the body’s natural healing process. Built on a commitment to high quality standards, evidence-based medicine and strong ethical behavior, Bioventus is a trusted partner for physicians worldwide.

For more information, visit www.BioventusGlobal.com and follow the company on Twitter @Bioventusglobal.

Bioventus, the Bioventus logo, and EXOGEN are registered trademarks of Bioventus LLC.

1. Azuma Y, Ito M, Harada Y, Takagi H, Ohta T, Jingushi S. Low-intensity pulsed ultrasound accelerates rat femoral fracture healing by acting on the various cellular reactions in the fracture callus. J Bone Miner Res. 2001; 16(4):671-680.
2. Nolte P, Anderson R, Strauss E, Hu L, J Jones, RG Steen. 2016. Heal rate of metatarsal fractures: A propensity-matching study of low-intensity pulsed ultrasound (LIPUS) vs. surgical and other treatments. Injury. 2017 47(11):2584-2590.
3. Zura R, G Della Rocca, S Mehta, A Harrison, C Brodie, J Jones, RG Steen. 2015. Treatment of chronic (> 1 year) fracture nonunion: Heal rate in a cohort of 767 patients treated with low-intensity pulsed ultrasound (LIPUS). Injury 46:2036-2041.
4. Zura R, S Mehta, G Della Rocca, J Jones, RG Steen. 2015. A cohort study of 4,190 patients treated with low-intensity pulsed ultrasound (LIPUS): Findings in the elderly versus all patients. BMC Musculoskel. Dis. 16:45.
5. Zura R, Xiong Z, Einhorn T, Watson JT, Ostrum RF, Prayson MJ, Della Rocca GJ, Mehta S, McKinley T, Wang Z, Steen RG. Epidemiology of Fracture Nonunion in 18 Human Bones, JAMA Surgery. 2016: e162775. doi:10.1001/jamasurg.2016.2775.

EXOGEN – Summary of Indications for Use in the US

*Summary of Indications for Use: The EXOGEN Ultrasound Bone Healing System is indicated for the non-invasive treatment of established non-unions* excluding skull and vertebra. In addition, EXOGEN is indicated for accelerating the time to a healed fracture for fresh, closed, posteriorly displaced distal radius fractures and fresh, closed or Grade I open tibial diaphysis fractures in skeletally mature individuals when these fractures are orthopaedically managed by closed reduction and cast immobilization. There are no known contraindications for the EXOGEN device. Safety and effectiveness has not been established for individuals lacking skeletal maturity; pregnant or nursing women; patients with cardiac pacemakers; on fractures due to bone cancer; or on patients with poor blood circulation or clotting problems. Some patients may be sensitive to the ultrasound gel. Full prescribing information can be found in product labeling, at www.exogen.com or by contacting customer service at 1-800-836-4080. *A nonunion is considered to be established when the fracture site shows no visibly progressive signs of healing.