CNYBAC Clients Achieve Major Milestones

Frank Middleton2

Quadrant Biosciences (https://quadrantbiosciences.com/)
Developing molecular diagnostic solutions for large-scale health issues.
Clarifi COVID-19 saliva test kit developed in partnership with SUNY Upstate Medical University (wastewater surveillance testing, pooled saliva testing, individual saliva testing)
Clarifi ASD® indicated for use in assessing the likelihood that a child has autism spectrum disorder (ASD) based on an evaluation of RNA epigenetic biomarkers in the saliva samples as well as key patient characteristics.
Clarifi mTBI™ novel and accurate biomarker for concussion in children.
Clarifi PD™ non-invasive saliva biomarker test in development to characterize Parkinson’s disease.
ClearEdge®Toolkit epigenetic diagnostic portable tool to assess longitudinal changes in cognitive function and balance, currently for research use only.
New full time jobs created:  98
New part time jobs created:  9
Jobs retained:  23

  • Designed, built and received NYS DOH License for 2 CLIA/CLEP high complexity laboratories for pooled saliva and individual Reflex testing using our Clarifi Covid 19 Test (July 2021).
    • Have processed 1.45M Clarifi Covid 19 tests (2021).
  • ELC Testing at K-12 schools in 36 counties in NYS includes over 400 school districts and 1,100 facilities (September 2021).
  • Operating community testing sites in 5 NY Counties, averaging 100 appointments daily.
  • Twenty-two patents pending for biomarker panels and diagnostic methods.
  • Continued partnership with Autism Speaks to support work in early diagnosis and intervention, as well as key research priorities, as part of our partnership to helping people with Autism and their families achieve the best long term outcome.
  • Offering NY businesses (with 100 or more employees) weekly COVID testing to meet new testing mandates. (September 2021).
  • Granted FDA Breakthrough Device Designation for innovative Clarifi ASD® autism saliva test (April 2021).
  • CEO, Richard Uhlig, named Top 50 Healthcare Technology CEOs of 2021 by The Healthcare Technology Report (April 2021).
  • Awarded Business of the Year in companies with more than 50 employees by CenterState CEO (April 2021).
  • Quadrant Biosciences and SUNY Upstate Medical University received MedTech 2020 Project of the Year Award for development of the Clarifi COVID-19 saliva test (January 2021).
  • FDA ranked SUNY Upstate Medical University and Quadrant Biosciences’ saliva test as the best of its kind in detecting COVID-19 and being among the most sensitive test regardless of type, ranking sixth worldwide in detecting the virus (December 2020).
  • Received FDA Emergency Use Authorization for Clarifi COVID-19 Test Kit, a saliva-based test to detect nucleic acid from the SARS-CoV-2 virus (September 2020).
  • Awarded $2.3M Fast Track (Phase I/II combined) STTR grant from the National Institutes of Health to develop an objective, saliva-based diagnostic tool for detecting concussion in children and adolescents. 
  • Received CPT® Proprietary Laboratory Analyses Code from the American Medical Association for its Clarifi ASD™ autism saliva test (April 2020).
  • Opens investment through equity crowdfunding platform (March 2020).
  • Launched first ever epigenetic saliva test for autism, Clarifi ASD™, the result of seven years of research at SUNY Upstate Medical University and Penn State College of Medicine (December 2019).
  • Awarded $330K from National Institutes of Health to be used for whole exome sequencing of 1000 children participating in ASD study (June 2019).
  • Awarded STTR Phase II $2M grant to refine and commercialize an epigenetic ASD diagnostic test (June 2019).
  • Recognized as NY Technology Business of the Year by the New York State Small Business Development Center (SBDC) (May 2019).
  • Partnered with leading edge genomic testing company, Admera Health headquartered in South Plainfield, NJ to perform laboratory testing (April 2018).

Zetagen Therapeutics (https://zetagen.com/)
Zetagen discovered and patented a new molecular pathway via a safe and proven small molecule which was originally approved by the FDA in 1971 to produce a truly inductive biologic to inhibit bone metastases and regenerate bone. 
ZetaMet™ is a synthetic, small-molecule, inductive biological technology being developed to target and resolve metastatic bone lesions while inhibiting future tumor growth and regenerating bone.
New full time jobs created:  1
New part time jobs created:  1
Jobs retained:  7
Federal grant funding acquired:  $2M NIH NCI Phase II grant

  • Awarded $2 Million two-year grant from the National Cancer Institute of the National Institutes of Health.  The grant will be used for the Phase 2 clinical trial and commercialization development of its ZetaMet™ technology (Zetagen Therapeutics Press Release, December 2021). 
  • Received FDA Breakthrough Device Designation for ZetaMet™ technology for treatment of metastatic bone cancers (Upstate in the News, December 2021).
  • Received Japanese patent (December 2021).
  • Received FDA Breakthrough Device Designation for ZetaFuseTM, a technology for use in patients undergoing spinal fusion surgery.  Covers the use throughout the entire spinal column. (July 2021).
  • Received authorization from Health Canada to conduct a Pivotal Trial for ZetaFuseTM evaluating the safety and efficacy in patients undergoing spinal fusion surgery (May 2021).
  • Received European patent for treatment of stimulating bone growth (April 2021) and Australian patent (July 2020).
  • Secured $5.34M in Series A funding round to accelerate the growth of clinical programs for ZetaMet™ (February 2020).
  • Awarded $225K SBIR grant from the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) of the National Institutes of Health.  Funding will support a Phase I validation study for molecular pathway designed to repair damaged bone through stem cell activation (September 2019).
  • Received US and South African patents (April 2019).
  • Awarded $300K SBIR grant from National Cancer Institute of the National Institutes of Health for Phase I validation study of drug-eluding implant (September 2018).

Repair Biotechnologies (https://www.repairbiotechnologies.com/)
Late stage preclinical-stage biotech company developing several first-in-class therapies based on innovative Cholesterol Degrading Platform.
Jobs retained:  5
Non-federal grant funding acquired:  $4.4M

  • Demonstrated efficacy of the Cholesterol Degrading Platform (CDP) therapy in the MS-NASH mouse model of nonalcoholic steatohepatitis, producing reversal of macrosteatosis and improvement in glucose tolerance.
  • Established a vivarium at the Upstate Medical University Department of Laboratory Animal Resources.

Aurie (https://livewithaurie.com/)
Reusable intermittent catheter system.
New full time jobs created:  2
New part time jobs created:  1
Jobs retained:  1
Federal grant funding acquired:  $20K, NSF I-Corps Supplement
Non-federal grant funding acquired:  $25K (University of Pittsburgh IMPACT program supplement)

  • Won FuzeHub Commercialization Competition Award
  • Awarded FuzeHub Manufacturing Grant
  • Awarded Small Business Innovation Research (SBIR) grants from National Science Foundation and National Institute of Disability, Independent Living and Rehabilitation Research
  • Accepted into VentureWell ASPIRE MedTech Program, raised $750K in funding through pre-seed round led by Lakehouse Ventures
  • Received FDA Safer Technology Designation from FDA 
  • Accepted into Harvard Innovation Labs’ Launch Lab X GEO Program
  • Serves as an MDIC Mentor

EndoGlow (https://www.endoglow.com/)
GreenEgg™, currently under development, designed for use in gynecologic, urologic, and colorectal surgeries, providing trans-illumination to enhance tissue visualization. 

  • Chosen by Med Tech Outlook as a Top 10 Minimally Invasive Device Solution Company

ZEPHYRx® (https://www.zephyrx.com/)
Spirometry technology/remote patient monitoring
Grew from 2 employees to 15 full-time employees

  • Received National Heart, Lung, and Blood Institute (NHLBI) SBIR grant for development and testing of breath-controlled video game for respiratory therapy
  • Resident company of Johnson & Johnson Innovation, JLABS, life science incubator program
  • Pivoted to bring telemedicine to lung patients during pandemic with unique software program for at-home pulmonary function testing; exploded nationally in telemedicine market
  • Cystic Fibrosis Foundation purchases devices for every patient with cystic fibrosis in the US

Cormac Life Sciences (https://www.cormaclifesciences.com/)
Providing expert consulting services for a number of biotech and pharmaceutical partners.  
Jobs retained:  2

  • Provided 3 physicians to various safety and data management boards for a range of biomedical products related to drug and vaccine development, inclusive of COVID countermeasure development.

Expressive Neuroscience (https://www.expressiveneuro.com/)
CRO with functional histology platform.
New full time jobs created:  1
New part time jobs created:  3
Non-federal grant funding acquired:  $50K

  • Currently have 5 active contracts with industry and academic labs.

Complex Biosystems
Establish strong credentials in electrophysiology and document the performance of our patented processing methods to interpret bioelectric data generated by isolated excitable cells, subjected to external electrical stimulation, for protein kinetics. This includes the effect of various drugs altering the electrical activity of excitable cells. A major focus is on cardiac drugs.
Jobs retained:  1
Non-federal grant funding acquired:  $35K

  • Presented at 2021 International Symposium on Biomedical Engineering and Computational Biology supported by Beihang University (August 2021)