OsteoDx Investing to Accelerate Commercialization

OsteoDx Investing to Accelerate Commercialization

OsteoDx Investing to Accelerate Commercialization

Along with additional TechGROWTH Fund investment, the OsteoDx has submitted for a Phase IIB SBIR Grant from the National Institutes of Health (NIH) and received favorable initial scoring to accelerate commercialization of its proprietary Cortical Bone Mechanics Technology™ (CBMT).

This investment will specifically enable OsteoDx to implement its detailed plan to obtain FDA approval for its CBMT device. Accelerating commercialization also means laying the foundation for future market adoption. The OsteoDx technology has the potential to significantly reduce the exponentially increasing healthcare cost of age-related bone fractures by providing a novel technology that can non-invasively and painlessly estimate whole bone strength.

The Market Demonstrates a Great Unmet Need

The grant proposal included letters of support from both medical researchers and venture capitalists, citing a high level of interest and support from the huge potential market. Among these was the Bone Health & Osteoporosis Foundation (BHOF, formerly National Osteoporosis Foundation), acknowledging the shortcomings of existing diagnostic modalities.

According to BHOF, an estimated 10 million Americans have osteoporosis; an additional 44 million Americans are at risk of a fracture. They cite a recent report that says Medicare beneficiaries suffered approximately 2.1 million osteoporotic fractures in 2016. It continues saying the total annual cost for osteoporotic fractures among Medicare beneficiaries was $57 billion in 2018.

A major barrier to reducing these costs is the inherent inaccuracies of current diagnostic technologies. CBMT’s potential ability to directly measure the mechanical properties of bone and estimate whole bone strength could prove useful to physicians and patients as it would be an additional piece of information about bone health to aid in the decision of whether someone needs treatment.

Read more about the Burden of Bone Disease from the US Surgeon General’s Report on Bone Health and Osteoporosis.

Toward the Goal of FDA Approval

Work to date of the OsteoDx team supports CBMT as a novel, highly accurate diagnostic tool for estimating bone strength, which promises strong clinical utility. Throughout development, the team has continuously modified the device design, adjusting for observations and feedback.

One of the first steps in preparing an application for FDA approval is to demonstrate the accuracy and clinical precision of the production device. The team will go on to document mechanical, electrical and software regulatory compliance required for a Class II de novo medical device FDA submission.

Immediate Future for OsteoDx, Inc.

In addition to preparing for the FDA application, the two-year timeline of the Phase IIb SBIR Grant includes clearing the path for success. While the research team focuses on the CBMT device itself, the leadership team will build out the talent and resources needed to launch commercial operations according to the OsteoDx revenue plan. Staffing, finance, and business development will be mapped and augmented strategically.

OsteoDx is located in the Innovation Center on the campus of Ohio University in Athens, Ohio. OsteoDx is currently conducting The STRONGER Study at 5 sites that are testing subjects utilizing CBMT devices.

AEIOU wins NASA Award

AEIOU wins NASA Award

AEIOU wins NASA’s Ignite the Night OHIO award for bone strength measurement technology

AEIOU Scientific, a TechGROWTH Ohio portfolio company that is working to commercialize their Cortical Bone Mechanics Technology (CBMT) to non-invasively assess bone strength, won NASA’s Ignite the Night OHIO award. This national program is designed to identify solutions to problems of interest to NASA, while connecting innovators with potential investors to fund further development and product commercialization.

Current diagnostic technologies that are designed to assess skeletal health do not determine actual bone strength. Instead, they mainly rely on assessing bone mineral density, which does not correlate well with strength nor adequately identifies patients at risk of fracture.

AEIOU’s proprietary technology aims to solve that problem by placing a vibrating ceramic probe against the forearm, which makes the bone under the skin vibrate in response. By using novel vibration analysis of bone strength, the company believes it will be able to provide a strong assessment of fracture risk.

In space, astronauts experience bone loss in their thighs of 1% to 1.5% mass per month and 6% to 10% over a six month stay, with recovery on Earth taking three to four years, according to research conducted by NASA. AEIOU’s CBMT for measuring bone strength, along with its shorter path to commercialization, gave it an edge over the other teams at the Ignite the Night OHIO event as NASA looks for bone loss solutions.

“By winning this award, our company has received tremendous external validation for CBMT,” AEIOU Chief Executive Officer Gary Wakeford said. “This emphasizes the need for a technology to identify and measure bone strength among people with osteoporosis and other bone diseases.”

Osteoporosis causes an average 2.3 million fragility fractures among Medicare patients every year, costing around $19 billion, according to a report published by the National Osteoporosis Foundation. “Osteoporosis treatment decisions are heavily driven by X-ray based measurements of bone mineral density and risk surveys. Unfortunately, these tools lack sufficient discriminatory sensitivity and accuracy to identify many individuals at high risk of experiencing a fragility fracture,” AEIOU Chief of Aging Research Brian Clark said.

Clark said CBMT has the potential to help physicians more accurately identify who would benefit from osteoporosis medications and monitor the effectiveness of the treatment. Wakeford estimates this market opportunity exceeds over $1 billion.

AEIOU is a medical technology start-up that spun out of technology developed at Ohio University. The commercialization efforts initially began a few years ago with funding from the Ohio University Innovation Strategy Program. This led to the creation of AEIOU, which has already received one grant from the National Institutes of Health and recently submitted another proposal to permit clinical testing of CBMT.

The company plans to sell the technology initially as a scientific instrument to bone research labs and universities in 2021. AEIOU will then use the data from these labs to apply for CBMT approval from the FDA. The company also plans to raise $1 million in seed funding.

“Ohio University has a robust innovation infrastructure baked into our culture,” Ohio University President M. Duane Nellis said. “Not only do we offer our faculty and professionals the institutional support to develop these types of groundbreaking technologies, but programs like TechGROWTH Ohio are also located right here at the University to provide the expertise, services and investments to grow start-up businesses and build our regional economy.”

Wakeford said that AEIOU’s success would have been hard to attain without assistance from TechGROWTH Ohio, which provided growth funding, support in selecting their current CEO, grant writing services to apply for the Small Business Innovation Research (SBIR) phase 2 application and an intern placement, in addition to ongoing guidance and advice.

“This award is a distinction that draws attention to the wonderful work that AEIOU is doing and the product they are trying to develop,” said Jane New, TechGROWTH’s manager of investments and new venture development. “It also demonstrates NASA’s recognition of the need of this technology for astronauts returning from space and its broad application in the public sector.”

The company is also an I-Corps@Ohio success story, which provided them hands-on training in evaluating market needs and commercial potential of groundbreaking technologies. AEIOU currently has offices in the Ohio University Innovation Center.

“The whole entrepreneurial ecosystem in Athens has been tremendously supportive,” Wakeford said. “We are receiving guidance from all facets here, including the Innovation Center and The Technology Transfer Office, which is actually the department that made us aware of the NASA opportunity. I think that speaks volumes to what a great place it is to be involved with an early-stage startup company.”

Key Publication Validates CBMT Accuracy

Key Publication Validates CBMT Accuracy

Inventors of CBMT validate accuracy of CBMT in leading journal, Bone. Bone. 2019 Mar;120:336-346. doi: 10.1016/j.bone.2018.11.018. Epub 2018 Nov 26.

Bowman L1, Ellerbrock ER2, Hausfeld GC3, Neumeyer JM2, Loucks AB4.





High error rates in the prediction of fragility fractures by bone mineral density have motivated searches for better clinical indicators of bone strength, and the high incidence of non-hip, non-spine fractures has raised interest in cortical bone. The aim of this study was to assess the accuracy of Cortical Bone Mechanics Technology™. CBMT is a new non-invasive 3-point bending technique for measuring the mechanical properties of cortical bone in the ulnas of living humans.


35 cadaveric human arms were obtained from small women and large men ranging widely in age (17 < Age < 99 years) and body size (14 < BMI < 40 kg/m2). Noninvasive CBMT measurements of the flexural rigidity of the ulna bones within these arms (EICBMT) were compared to measurements of EI by Quasistatic Mechanical Testing in the ulnas excised from those arms (EIQMT). Ulna bending strength was also measured by QMT as the peak moment before fracture (Mpeak). The open source BoneJ plugin to ImageJ image processing software was used to calculate cortical porosity (CP) in micro-computed tomography images of a 2 mm length of the mid-shaft of each fractured ulna, and the interosseous diameter (IOD) of each ulna was also measured in those images.


EICBMT measurements (13 < EICBMT < 97 Nm2) explained 99% of the variance in QMT measurements of ulna bending strength (11 < Mpeak < 90 Nm), but EICBMT was biased high by 30% (p < 0.0001) relative to EIQMT (11 < EIQMT < 69 Nm2). After correcting this bias, EICBMT and EIQMT measurements lay along the identity line (y = 1.00x, R2 = 0.99, SEE = 3.1 Nm2). Predictions of Mpeak by EICBMT were less accurate than predictions by EIQMT (both R2 = 0.99; SEECBMT = 5.9 Nm vs SEEQMT = 4.5 Nm, F = 2.92, p = 0.001), but EICBMT predictions were substantially more accurate than those by IOD (R2 = 0.79; SEEIOD = 10.6 Nm, F = 3.30, p < 0.001) and CP (R2 = 0.35; SEECP = 18.9 Nm, F = 10.45, p < 10-9). Predictions by EICBMT were also more accurate than predictions by arm donor height (R2 = 0.63; SEE = 14.3 Nm, F = 5.87, p < 10-6), body weight (R2 = 0.77; SEE = 11.1 Nm, F = 3.54, p < 0.001) and BMI (R2 = 0.64; SEE = 14.1 Nm, F = 2.39, p < 0.01). In forward stepwise multiple regression beginning with EICBMT, only age explained any additional variance in ulna bending strength (ΔR2 = 0.3%, F = 8.03, p = 0.008).


Noninvasive CBMT measurements of ulna EI explain 99% of individual differences in QMT measurements of ulna bending strength in cadaveric human arms.


Bone fragility; Bone mechanics; Bone strength; Cortical bone; Cortical porosity; Ulna


Author information

2 Department of Biological Sciences, Ohio University, Athens, OH 45701, United States of America.
3 Honors Tutorial College, Ohio University, Athens, OH 45701, United States of America.
4 Department of Biological Sciences, Ohio University, Athens, OH 45701, United States of America; Ohio Musculoskeletal and Neurological Institute, Ohio University, Athens, OH 45701, United States of America. Electronic address: loucks@ohio.edu.
Key Publication Validates CBMT Accuracy

P3 Automated robotic CBMT scientific instrument is evaluated

July, 2017.  Anne Loucks begins testing the measurement accuracy and repeatability of her first Cortical Bone Mechanics Technology™ (CBMT™) scientific instrument P3.  P3 is an automated robot incorporating Ohio University’s improvements to MRTA technology.  Key opinion leaders in osteoporosis medical practice advise that it must be more than just safe and effective for its intended use as the FDA requires.  It must also be pretty in order for physicians to buy it.  This stimulates a wholesale redesign.

Key Publication Validates CBMT Accuracy

Publications and Patent Filings begin for CBMT

March 2012.  Anne Loucks begins testing the accuracy of her MRTA prototype medical device P2 by comparing MRTA and QMT measurements of EI in artificial human ulna bones.  The results are later published in the Journal of Biomechanics.  Methods for improving the accuracy of MRTA measurements begin to emerge.

April, 2013.  Ohio University files its first patent application for improvements to MRTA invented by Lyn Bowman and two undergraduate Biological Sciences students.

June 2013.  Anne Loucks begins testing the accuracy of her MRTA prototype medical device P2 by comparing MRTA and QMT measurements of EI in cadaveric human arms.  Further methods for improving the accuracy of MRTA measurements emerge