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Orthobiologics remains an area ripe for advancement, particularly in improving ease of use and safety profile. Startup companies are developing new approaches designed to address those unmet needs.
At the NASS Innovation NetWORK Summit last month, 15 spine-related companies pitched in front of surgeons, investors and industry. Among companies developing smart implants and enabling technologies, the orthobiologics startups stood out to attendees, who rated the companies on their clinical innovation.
Here, we highlight three of those companies, noting their products, development status and funding prospects.
Renovos
Renovos is developing RENOVITE BMP-2, a synthetic nanoclay gel, as an alternative to bone graft materials for spinal fusion. The injectable gel allows precise, localized bone formation at the target site and retains biological molecules, so there’s no diffusion release from the material. One gram of RENOVITE provides a surface area roughly equivalent to that of a tennis court, allowing the company to reduce the required BMP-2 dose — and ultimately the product’s cost — compared with existing technologies.
Studies show that the nanoclay gel absorbs and binds proteins from blood, creating a more viscous material that stays where it is placed without BMP-2 leaching. The BMP-2 is tightly bound within the nanogel structure, only allowing the cells invading the material to be exposed and break down at the same time the patient’s own regenerative process is forming bone.
Despite decades of use, there are no products that provide a safe, reliable and effective way to deliver bone-forming biologics, said Agnieszka Janeczek, Ph.D., Co-Founder and CEO of Renovos. “We have to deliver BMP-2 to form bone in a safe way,” she said. “We need to apply a more transformative approach toward the carrier to be able to safely retain the protein where it’s needed, and that’s what our material does.”
RENOVITE can be injected through a 23-gauge needle, allowing it to be used in open or minimally invasive spine procedures.
It’s expected to be a platform technology, with orthobiologics as its first application. Renovos is also studying the technology for microfracture and other orthopedic fusion applications, as well as use in cell delivery and implant coatings.
Renovos received an FDA Breakthrough Device Designation in 2024. The company is raising a $4 million Series A, which will be used to complete preclinical development and a large sheep study.
Amphix Bio
Amphix Bio’s core technology is made of supramolecular peptide amphiphiles. Its first product, AMFX-100, is designed to bind BMP-2 and treat degenerative disc disease with transforaminal lumbar interbody fusion procedures.
AMFX-100 captures the patient’s own BMP-2 and binds it to supramolecular peptide amphiphiles that instruct cells to initiate regenerative processes and restore function. These molecules contain tens of thousands of biological signals that activate regenerative signaling pathways while forming scaffolds to support tissue growth.
Amphix Bio’s technology enables effective regeneration of cells and tissues without the manufacturing challenges and safety concerns of approaches like cell therapies, said Nick Sather, Ph.D., Co-founder and CEO.
“Typically, people think about cell or gene therapies when they hear the word regeneration,” Dr. Sather said. “Those are potentially highly potent, but haven’t gained clinical traction because of their scalability issues. On the flip side, you have biomaterials, which are more inherently scalable but lack regenerative potential. We’re developing therapies that trigger regeneration using a patient’s own cells.”
AMFX-100 comes in a ready-to-use putty formation to enhance the product’s stability, potency and ease of use. FDA granted Amphix Bio Breakthrough Device Designation for AMFX-100, labeling it a drug/device combination product for bone regeneration.
Amphix Bio’s pipeline includes bone, neural and cartilage regeneration programs, with its second product focused on spinal cord lesions.
The company raised $12.5 million in a seed round in 2025. The funding will be used for further pipeline development and to support completion of its preclinical sheep testing.
Lenoss Medical
Lenoss Medical has developed the OsteoPearl system, a fully biological solution intended to repair compression fractures in vertebrae. OsteoPearl consists entirely of cortical bone arranged into flexible, linked pearls that are designed to create a 3-D structural matrix for immediate stability of the vertebrae. OsteoPearl becomes flexible once in saline and is inserted using a technique similar to standard kyphoplasty.
An estimated 1.5 million vertebral compression fractures occur each year in the U.S., and following an initial fracture, there is a 19% chance of an additional fracture within the next 12 months, according to Lenoss Medical.
Dom Messerli, Co-founder, President and CEO of the company, said OsteoPearl stimulates healing and bone growth while avoiding the complications associated with traditional cement.
“The standard of care used today is injectable PMMA bone cement, and unfortunately, liquid cement has the chance to leak out of the vertebral bodies into the patient’s heart and lungs,” Mr. Messerli said, noting that cement leakage occurs in approximately one in five procedures.
OsteoPearl has been implanted more than 450 times with no known leakage into the bloodstream. Mr. Messerli said the pearls are nearly 4 millimeters in diameter and swell to about 30% in volume once implanted, creating a stable implant that is unlikely to migrate into the venous system.
Lenoss Medical is conducting a short-term and a long-term study and raising $10 million in a Series B. The company raised $13 million in previous funding rounds and has more than 23 patents issued.
Renovos, Amphix Bio and Lenoss Medical are pursuing different approaches to a common goal: improving bone healing while reducing the limitations and risks associated with current orthobiologic and structural repair technologies in the spine.
Orthobiologics remains an area ripe for advancement, particularly in improving ease of use and safety profile. Startup companies are developing new approaches designed to address those unmet needs.
At the NASS Innovation NetWORK Summit last month, 15 spine-related companies pitched in front of surgeons, investors and industry. Among companies...
Orthobiologics remains an area ripe for advancement, particularly in improving ease of use and safety profile. Startup companies are developing new approaches designed to address those unmet needs.
At the NASS Innovation NetWORK Summit last month, 15 spine-related companies pitched in front of surgeons, investors and industry. Among companies developing smart implants and enabling technologies, the orthobiologics startups stood out to attendees, who rated the companies on their clinical innovation.
Here, we highlight three of those companies, noting their products, development status and funding prospects.
Renovos
Renovos is developing RENOVITE BMP-2, a synthetic nanoclay gel, as an alternative to bone graft materials for spinal fusion. The injectable gel allows precise, localized bone formation at the target site and retains biological molecules, so there’s no diffusion release from the material. One gram of RENOVITE provides a surface area roughly equivalent to that of a tennis court, allowing the company to reduce the required BMP-2 dose — and ultimately the product’s cost — compared with existing technologies.
Studies show that the nanoclay gel absorbs and binds proteins from blood, creating a more viscous material that stays where it is placed without BMP-2 leaching. The BMP-2 is tightly bound within the nanogel structure, only allowing the cells invading the material to be exposed and break down at the same time the patient’s own regenerative process is forming bone.
Despite decades of use, there are no products that provide a safe, reliable and effective way to deliver bone-forming biologics, said Agnieszka Janeczek, Ph.D., Co-Founder and CEO of Renovos. “We have to deliver BMP-2 to form bone in a safe way,” she said. “We need to apply a more transformative approach toward the carrier to be able to safely retain the protein where it’s needed, and that’s what our material does.”
RENOVITE can be injected through a 23-gauge needle, allowing it to be used in open or minimally invasive spine procedures.
It’s expected to be a platform technology, with orthobiologics as its first application. Renovos is also studying the technology for microfracture and other orthopedic fusion applications, as well as use in cell delivery and implant coatings.
Renovos received an FDA Breakthrough Device Designation in 2024. The company is raising a $4 million Series A, which will be used to complete preclinical development and a large sheep study.
Amphix Bio
Amphix Bio’s core technology is made of supramolecular peptide amphiphiles. Its first product, AMFX-100, is designed to bind BMP-2 and treat degenerative disc disease with transforaminal lumbar interbody fusion procedures.
AMFX-100 captures the patient’s own BMP-2 and binds it to supramolecular peptide amphiphiles that instruct cells to initiate regenerative processes and restore function. These molecules contain tens of thousands of biological signals that activate regenerative signaling pathways while forming scaffolds to support tissue growth.
Amphix Bio’s technology enables effective regeneration of cells and tissues without the manufacturing challenges and safety concerns of approaches like cell therapies, said Nick Sather, Ph.D., Co-founder and CEO.
“Typically, people think about cell or gene therapies when they hear the word regeneration,” Dr. Sather said. “Those are potentially highly potent, but haven’t gained clinical traction because of their scalability issues. On the flip side, you have biomaterials, which are more inherently scalable but lack regenerative potential. We’re developing therapies that trigger regeneration using a patient’s own cells.”
AMFX-100 comes in a ready-to-use putty formation to enhance the product’s stability, potency and ease of use. FDA granted Amphix Bio Breakthrough Device Designation for AMFX-100, labeling it a drug/device combination product for bone regeneration.
Amphix Bio’s pipeline includes bone, neural and cartilage regeneration programs, with its second product focused on spinal cord lesions.
The company raised $12.5 million in a seed round in 2025. The funding will be used for further pipeline development and to support completion of its preclinical sheep testing.
Lenoss Medical
Lenoss Medical has developed the OsteoPearl system, a fully biological solution intended to repair compression fractures in vertebrae. OsteoPearl consists entirely of cortical bone arranged into flexible, linked pearls that are designed to create a 3-D structural matrix for immediate stability of the vertebrae. OsteoPearl becomes flexible once in saline and is inserted using a technique similar to standard kyphoplasty.
An estimated 1.5 million vertebral compression fractures occur each year in the U.S., and following an initial fracture, there is a 19% chance of an additional fracture within the next 12 months, according to Lenoss Medical.
Dom Messerli, Co-founder, President and CEO of the company, said OsteoPearl stimulates healing and bone growth while avoiding the complications associated with traditional cement.
“The standard of care used today is injectable PMMA bone cement, and unfortunately, liquid cement has the chance to leak out of the vertebral bodies into the patient’s heart and lungs,” Mr. Messerli said, noting that cement leakage occurs in approximately one in five procedures.
OsteoPearl has been implanted more than 450 times with no known leakage into the bloodstream. Mr. Messerli said the pearls are nearly 4 millimeters in diameter and swell to about 30% in volume once implanted, creating a stable implant that is unlikely to migrate into the venous system.
Lenoss Medical is conducting a short-term and a long-term study and raising $10 million in a Series B. The company raised $13 million in previous funding rounds and has more than 23 patents issued.
Renovos, Amphix Bio and Lenoss Medical are pursuing different approaches to a common goal: improving bone healing while reducing the limitations and risks associated with current orthobiologic and structural repair technologies in the spine.
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Carolyn LaWell is ORTHOWORLD's Chief Content Officer. She joined ORTHOWORLD in 2012 to oversee its editorial and industry education. She previously served in editor roles at B2B magazines and newspapers.
