Locate Bio’s Chondro3 Granted FDA Breakthrough Device Designation

Novel cartilage regenerative product, Chondro3 is a biomimetic graft for osteochondral lesions

The Company’s second FDA Breakthrough Device designation granted in 2021

Locate Bio, an orthobiologics focused regenerative medicine company, is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation to Chondro3, currently in development as a biomimetic graft for osteochondral lesions. The FDA Breakthrough Device Program is designed to accelerate patient access to promising technologies that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions.

Osteochondral lesions are a tear or fracture that involves damage to both the cartilage and underlying bone. Osteochondral defects often occur in joints and are most common in the articular cartilage and subchondral bone structures of the knee and ankle. Articular cartilage injuries often occur following an acute traumatic injury or an underlying bone disorder. The lack of intrinsic tissue healing capacity of cartilage leaves many people on the path to degenerative osteoarthritis, chronic pain and potential total knee replacement surgery , all of which place a significant burden on the world’s healthcare systems. It is estimated that over 60% of the 1 million knee arthroscopies performed in the U.S. each year involves a chondral lesion , representing a potential market opportunity in excess of $1bn .

Chondro3 has been designed to be a truly regenerative product that has significant potential to address this growing unmet medical need. It is a three layered, proprietary collagen-based biodegradable matrix that can be delivered in a single procedure, in an out-patient setting and at an affordable price. It is designed to provide a scaffold for cellular and tissue in-growth and osteochondral defect repair at the site of lesion, supporting the biomimetic repair of both cartilage (chondrogenesis) and bone (osteogenesis). Chondro3 has been shown in peer-reviewed, pre-clinical studies that it can regenerate long-lasting hyaline cartilage , which is critical to long term outcomes.

John von Benecke, CEO of Locate Bio, said:

“We are delighted to have been granted our second Breakthrough Device designation from the FDA, this time for Chondro3, our exciting biomimetic graft for osteochondral lesions. There is an enduring unmet need for a cost-effective regenerative treatment, and we are proud that the FDA has recognised the potential of Chondro3 to address this serious public health issue. Having received two Breakthrough Device Designations this year, we are gaining real momentum towards achieving our ambition of building a world-leading orthobiologics business that addresses clear unmet needs of both surgeons and patients. We look forward to further progressing Chondro3 through the next stages of development to regulatory approval, and to discussing opportunities with potential partners who share our vision for this product.”

Keith Valentine, Non-Executive Chair of Locate Bio, said:

“This is another important milestone for Locate Bio. There is a significant unmet need for effective new orthobiologic products that improve the options available to surgeons in this area. We believe Chrondro3 is a very exciting product that has significant potential to improve the outcomes of hundreds of thousands of patients suffering from osteochondral lesions.”

In January 2021, Locate Bio was granted a Breakthrough Device designation from the FDA for its investigational treatment for chronic osteomyelitis, CognitOss. CognitOss is a drug-device combination product for the treatment of chronic infections within bone. It has a unique antibiotic release profile, targeting both improvements in the elimination of infection, and the regeneration of bone at the infection site. These Breakthrough Device designations underscore Locate Bio’s innovative product offerings focused on improving patient lives.

ENDS

About Locate Bio

Locate Bio is an innovative orthobiologics company with a proprietary, regenerative medicine pipeline, delivering exciting orthobiologics products that have great disruptive potential.

Locate Bio’s ambition is to build a world leading, orthobiologics business with a diversified suite of best-in-class technologies that address the performance limitations of existing products and enable orthopaedic surgeons to improve the lives of people suffering from debilitating conditions.

In September 2020, Locate Bio announced the acquisition of multiple late stage complementary orthobiologics assets from Royal College of Surgeons in Ireland (RCSI) University of Medicine and Health Sciences, accelerating its route to market and broadening its orthobiologics pipeline. Locate’s portfolio now includes CertOss, a semi-synthetic graft substitute; CognitOss, the same graft substrate as CertOss but designed to elute antibiotics for the treatment of osteomyelitis; LDGraft a low dose, controlled release rhBMP-2 spinal fusion product intended for the treatment of lower back pain caused by degenerative disc disease; and Chondro3, a three-layer cartilage repair graft. The Company continues to look for partnering opportunities, both in-licencing or out-licencing that would further its aim of providing surgeons with a choice of best-in-class technologies and products that address the current challenges of existing products and meet specific patient driven clinical needs.

Locate Bio is a spin-out from the University of Nottingham. The Company is backed by Mercia Asset Management PLC.

To learn more visit: https://www.locatebio.com/

For further information:

Locate Bio Limited
John von Benecke, CEO
+44 (0)115 784 0041
jvonbenecke@locatebio.com

Media enquiries

FTI Consulting
Stephanie Cuthbert, Ciara Martin

+44 (0) 203 727 1000
LocateBio@fticonsulting.com

CognitOss Granted FDA Breakthrough Device Designation

CognitOss is designed to treat osteomyelitis, a debilitating inflammatory bone infection

FDA’s Breakthrough Device Program helps accelerate patient access to more effective treatments

Locate Bio, an orthobiologics focused regenerative medicine company, is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation to CognitOss, currently in develoment for the treatment of chronic osteomyelitis. The FDA Breakthrough Device Program is intended to help patients receive more timely access to certain technologies that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions.

Osteomyelitis is a progressive, inflammatory infection of the bone, usually caused by bacteria and is estimated to account for up to 50% of all non-trauma related amputations. Currently, the standard treatment for chronic osteomyelitis is surgical debridement, long-term, high-dose administration of antibiotics, and – for larger defects – bone grafting which often requires a second surgical procedure to remove the non-resorbable bone graft. CognitOss is intended to offer surgeons a single surgical procedure alternative, combining a fully resorbable bone graft with best-in-class bone healing properties and a proprietary dual-phasic release of antibiotics, to initially provide a bolus release at the site of the infection and then prevent re-infection through a further controlled release. CognitOss is intended to be used as an adjuvant to oral or intravenous antibiotics, to prevent colonization of the graft material.

CognitOss uses the same bone graft substitute architecture as Locate Bio’s CertOss, a new class of composite collagen product that delivers a leading bone formation response(1). 510(k) submission for CertOss is planned in 2022.

CognitOss is designed to extend the capabilities of this bone graft with a dual-phasic and uniquely responsive antibiotic release mechanism that releases higher levels of antibiotic in the presence of infection, all whilst repairing the bone void. The need for such a product is currently greater than ever, with the global incidence of osteomyelitis substantially increasing in recent years, in part due to an increase of risk factors such as diabetes(2). First in human studies of CognitOss are planned in 2022.

John von Benecke, CEO of Locate Bio, said:

“We are delighted that CognitOss has been granted Breakthrough Device designation by the FDA. CognitOss is designed to address the enduring unmet clinical need of osteomyelitis patients, through a novel, single-stage therapy that combines the local delivery of therapeutically appropriate levels of antibiotics with an effective, biodegradable, state-of-the-art material that promotes the regeneration of bone. We look forward to progressing CognitOss through its regulatory pathway and into clinical trials.”

Keith Valentine, Non-Executive Chair, said:

“This is another important step towards Locate’s ambition of building a world leading, diversified orthobiologics company. We have a clear focus on bringing novel, best-in-class products to the market, in a range of orthopaedic indications, that can provide improved options for surgeons and, in turn, improve the lives of millions of patients.”

ENDS

About Locate Bio

Locate Bio is an innovative orthobiologics company with a proprietary, regenerative medicine pipeline, delivering exciting orthobiologics products that have great disruptive potential.

Locate Bio’s ambition is to build a world leading, diversified suite of best-in-class technologies that address the performance limitations of existing products and enable orthopaedic surgeons to improve the lives of people suffering from debilitating conditions.

In September 2020, Locate Bio announced the acquisition of multiple late stage complementary orthobiologics assets from Royal College of Surgeons in Ireland (RCSI) University of Medicine and Health Sciences, accelerating its route to market and broadening its orthobiologics pipeline. Locate’s portfolio now includes CertOss, a semi-synthetic graft substitute; CognitOss, the same graft substrate as CertOss but designed to elute antibiotics for the treatment of osteomyelitis; LDGraft a low dose, controlled release rhBMP-2 spinal fusion product intended for the treatment of lower back pain caused by degenerative disc disease; and Chondro3, a three-layer cartilage repair graft. The Company continues to look for additional, complementary acquisitions or in-licencing opportunities that would further broaden its portfolio to provide surgeons with a choice of best-in-class technologies and products that address the current challenges of existing products and meet specific patient driven clinical needs.

Locate Bio is a spin-out from the University of Nottingham. The Company is backed by Mercia Asset Management PLC.

To learn more visit: https://www.locatebio.com/

For further information:

Locate Bio Limited
John von Benecke, CEO
+44 (0)115 784 0041
jvonbenecke@locatebio.com

Media enquiries

FTI Consulting
Stephanie Cuthbert, Ciara Martin

+44 (0) 203 727 1000
Stephanie.cuthbert@fticonsulting.com

References:

(1) Murphy CM, Schindeler A, Gleeson JP, Yu NY, Cantrill LC, Mikulec K, Peacock L, O’Brien FJ, Little DG. A collagen-hydroxyapatite scaffold allows for binding and co-delivery of recombinant bone morphogenetic proteins and bisphosphonates. Acta Biomater. 2014 May;10(5):2250-8. doi: 10.1016/j.actbio.2014.01.016. Epub 2014 Jan 21. PMID: 24456759.

(2) Kremers HM, Nwojo ME, Ransom JE, Wood-Wentz CM, Melton LJ, Huddleston PM. Trends in the epidemiology of osteomyelitis: a population-based study, 1969 to 2009. J Bone Joint Surg Am. 2015 May 20;97(10):837-45.

Locate Bio appoints Keith Valentine as the Non-Executive Chair of the Board of Directors

Another important step towards its ambition of building a world leading, diversified orthobiologics company

Locate Bio, an orthobiologics focused regenerative medicine company, is pleased to announce the appointment of Keith Valentine as the Non-Executive Chair of the Board with immediate effect. Keith joins with over 30 years’ experience in the orthopaedic industry, encompassing various leadership and senior executive positions in marketing, development and operations.

Since May 2015, Keith has served as the Chief Executive Officer and President of SeaSpine, a global medical technology company focused on surgical solutions for the treatment of spinal disorders, where he has successfully expanded the business and delivered significant revenue growth. He joined SeaSpine from NuVasive, a leader in spine technology innovation, where he spent 14 years in various senior roles including President and Chief Operating Officer from 2007 to 2015. Prior to this, he served as Vice President of Marketing at ORATEC Interventions, which was acquired by Smith and Nephew PLC in 2002, and also spent eight years in various roles with Medtronic Sofamor Danek, including as Vice President of Marketing for the Rods division and Group Director for the BMP Biologics program, the Interbody Sales Development Effort, and International Sales and Marketing.

John von Benecke, CEO of Locate, said:

“We are thrilled to welcome Keith to the Locate team. This is an exciting appointment that further demonstrates the momentum we are building as an orthobiologics business. Keith has an amazing pedigree and we are delighted to have attracted someone of his calibre and proven track record to the business. His considerable wealth of experience at some of the sector’s biggest names will be invaluable in supporting Locate Bio as we continue to execute on our strategy of building a world-leading, diversified orthobiologics company.”

Keith Valentine, Non-Executive Chair, said:

“I am delighted to be joining the Board of Locate Bio at this exciting stage, and look forward to working with the Company as it continues to progress its differentiated portfolio of best-in-class orthobiologics technologies. There is a significant unmet need for effective orthobiologic products, that provide improved options to surgeons in a range of indications. Locate Bio has an exciting pipeline of innovative products that have real disruptive potential and could improve the lives of the millions of people suffering from debilitating conditions.”

The appointment follows the Company’s recent acquisition of multiple late stage complementary orthobiologics assets from Royal College of Surgeons in Ireland (RCSI) University of Medicine and Health Sciences, accelerating its route to market and broadening its orthobiologics pipeline. The Company continues to look for additional, complementary acquisitions or in-licencing opportunities that would further broaden its portfolio to provide surgeons with a choice of best-in-class technologies and products that address the current challenges of existing products and meet specific patient driven clinical needs.

ENDS

About Locate Bio

Locate Bio is an innovative orthobiologics company with a proprietary, regenerative medicine pipeline, delivering exciting orthobiologics products that have great disruptive potential.

Locate Bio’s ambition is to build a world leading, diversified suite of best-in-class technologies that address the performance limitations of existing products and enable orthopaedic surgeons to improve the lives of people suffering from debilitating conditions. Locate Bio’s lead asset in development, is a low dose, controlled release rhBMP-2 spinal fusion product intended for the treatment of lower back pain caused by degenerative disc disease.

Locate Bio is a spin-out from the University of Nottingham and based on the research of Professor Kevin Shakesheff, a world-leading expert in regenerative medicine. The Company is backed by Mercia Asset Management PLC.

To learn more visit: https://www.locatebio.com/

For further information:

Locate Bio Limited
John von Benecke, CEO
+44 (0)115 784 0041
jvonbenecke@locatebio.com

Media enquiries

FTI Consulting
Stephanie Cuthbert, Ciara Martin

+44 (0) 203 727 1000
Stephanie.cuthbert@fticonsulting.com