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Category: Portfolio Companies

FDA issues guidance on conduct of clinical trials during the COVID-19 pandemic

Posted on March 23, 2020 by Jim Jordan

To Our Community,

The impact of COVID-19 on our personal and business lives has been, and will continue to be, significant. New guidance from the FDA specifically outlines how the virus will impact clinical trials, both those that are ongoing, as well as those yet to begin (“FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic”).

The State of Pennsylvania Department of Community and Economic Development (DCED) is making resources available to help businesses through this uncertain time through its COVID-19 Resources website.

Being faced with so much unknown, this pandemic has caused disruption, stress, and fear. With the need for new vaccines and treatments, we in the life sciences are tasked with bringing the best and brightest minds together to find solutions. At the Pittsburgh Life Sciences Greenhouse, we are honored to be a part of this effort through our portfolio company, CytoAgents.

CytoAgents is working on an immunotherapy that is easily administered and cost effective, increasing its ability to make a positive global impact. With their oral treatment, the inflammation response that is triggered by a virus will be controlled more effectively. And unlike anti-viral medications, there is no risk of resistance or possibility of not working as the virus mutates. This is revolutionary and exciting, and it brings a sense of hope.

Please be careful, mindful of others, and adhere to the CDC guidelines.

 

Posted in Uncategorized, Words of Wisdom, Portfolio Companies, TherapeuticsLeave a comment

Meet our Companies: Therapeutics Innovators in the PLSG Portfolio

Posted on July 8, 2019 by Jim Jordan

Meet our Companies: Therapeutics Innovators in the PLSG Portfolio

Healthcare is changing at a rapid pace and technology is one impetus behind the evolution. Organizations like the Pittsburgh Life Sciences Greenhouse have the privilege of supporting and nurturing the innovative companies that are propelling the industry forward into a new age. In our last blog, we took a closer look at the medical device companies we’re working with. We’d now like to introduce you to some the other companies in our portfolio. The organizations in this overview come from our Therapeutics category.

What is Therapeutics?

Simply put, therapeutics deals specifically with the treatment of disease. Several of the companies in our portfolio are currently in pre-clinical and clinical stages of product development. It’s exciting to walk with them on this journey of research, development and trialing their innovative treatments. The innovative entrepreneurs behind these companies are striving to treat a wide range of diseases and disorders.

Complexa

Complexa is a clinical-stage biopharmaceutical company focused on developing a new a new class of drugs to treat patients with severe and life-threatening fibrosis and inflammatory diseases. The company aims to create treatments that will prevent and repair tissue injury, as well as reverse fibrosis and inflammation.

Lipella Pharmaceuticals

Chemotherapy and radiation treatments may create their own collateral damage when used to treat cancer patients. Lipella Pharmaceuticals is developing products that can provide supportive care for cancer survivors with hemorrhagic cystitis. The company also has other urinary bladder conditions products in the pipeline.

Qrono

Qrono Inc, enables medications, patient adherence, patient outcomes and faster time-to-market using an innovative technology to create long-acting injectable formulations.

Sharp Edge Labs

This therapeutics company is developing small molecule drugs for genetic disorders of protein trafficking. The technology Sharp Edge Labs enables the dissection of each step in the lifecycle of a protein in order to better understand the trafficking of the target as well as defects in trafficking caused by mutation.

Cognition Therapeutics

Cognition Therapeutics (CogRX) is developing a small molecule therapeutics targeting the toxic proteins that cause cognitive decline associated with Alzheimer’s disease and related neurodegenerative diseases. Earlier this year, the company published clinical data from its Phase 1 trial of its drug Elayta in Alzheimer’s & Dementia: Translational Research & Clinical Interventions.

Knopp Biosciences

Knopp Biosciences seeks to discover, develop and deliver medicines to treat diseases that impose high costs on the healthcare system. Currently their research has led to an investigational compound in clinical development for immunological and hematological disorders, as well as discovery platforms directed to small molecule mediators of epilepsy and neuropathic pain.

Peptilogics

The early-stage biotechnology company Peptilogics is developing systemic anti-infective drugs called Engineered Cationic Antibiotic Peptides (eCAPs). Current pre-clinical data indicate that eCAPS may be effective in treating drug-resistant hospital-acquired infections.

These companies represent just one category of the PLSG portfolio. In addition to these innovative therapeutics companies, we also work with organizations that are shaking things up in the area of Medical Devices, Health IT, Diagnostics, and Bio Tools. You can learn more about those companies here.

Posted in Uncategorized, Portfolio Companies, TherapeuticsLeave a comment

Meet our Companies: Medical Device Innovators in the PLSG Portfolio

Posted on June 24, 2019 by Jim Jordan

This is an exciting time to be involved in life sciences. Our industry is rapidly evolving. Some of that, of course, is connected to the shift in healthcare paradigms as dictated by policy changes and new business models. Another factor, however, is the rapid pace of health technology innovation. Here, at the Pittsburgh Life Sciences Greenhouse, we have the privilege of seeing some of these game changers grow from an idea into a company. In fact, we have worked with nearly 500 companies and scores of entrepreneurs in all aspects of life sciences: Biotech Tools, Diagnostics, Medical Devices, Therapeutics and Health IT. Today, we invite you to meet some of the medical device companies within our portfolio.

ALung Technologies

ALung Technologies respiratory assist system, called Hemolung (RAS), is for patients with acute exacerbations of chronic obstructive pulmonary disease, a $6.3B worldwide market. Clinical trials are currently underway.

Carmell Therapeutics

Carmell Therapeutics has developed plasma-based bioactive materials (PMA) that contain a concentration of natural regenerative factors that promote healing, reduce complications, and save healthcare costs. The company recently announced the publication of the results of its pre-clinical studies on its tissue healing accelerant for the treatment of cutaneous radiation injury.

Medrobotics

Medrobotics’ flagship product is the Flex® Robotic System, a robot-assisted platform that provides physicians with single-site access and visualization of hard-to-reach anatomical locations. Medrobotics co-founder Howie Choset was recently awarded the 2019 Engelberger Robotics Award for Education in part for his work on the Flex Robotic System.

Quantum OPS

Quantum OPS develops devices that facilitate the effortless, rapid, and secure positioning of a patients’ shoulder, arm, hip or knee for surgery. These devices can be used to safely support anesthetized patients in the proper position for several hours during surgery.

ViaTherm Therapeutics

ViaTherm Therapeutics is an industry leader in diathermy technology. Their therapeutic deep heating products can reduce the pain associated with injury and aging while helping to promote flexibility, mobility and assist circulation.

ChemDAQ Inc.

ChemDAQ Inc.’s toxic (sterilant) gas monitoring systems protect workers from exposure to airborne toxins. The system was originally used in hospital and medical device sterilization operations in the US. It has since expanded internationally and to other industries such as food and beverage processing, water treatment facilities and other industries that use Peracetic Acid, Hydrogen Peroxide or Ethylene Oxide.

Forest Devices

Forest Devices’ ALPHASTROKE helps first responders quickly identify whether a patient has had a stroke so they can route the patient to the proper hospital. This ability to identify and triage stroke victims in the field can reduce the time it takes to begin treatment. This is significant as early treatment can prevent up to 6,000 deaths per year.

Neuro Kinetics

Neuro Kinetics, Inc. (NKI) has developed a unique, eye-tracking technology to be used for non-invasive, neuro-otologic diagnostic testing. The company is expanding its applications to include concussions and is currently conducting clinical trials.

Circadiance

Circadiance has developed respiratory products for individuals with sleep-disordered breathing. These patients need non-invasive ventilation or require monitoring. The company has innovated a collection of comfortable, breathable, easy-care cloth respiratory products designed to improve the patient compliance rate. Circadiance’s NeoPAP CPAP is designed to treat newborns and infants with (or recovering from) respiratory distress syndrome.

Intelomed

Intelomed has redefined the standard of patient monitoring and informatics with their non-invasive device that dynamically assesses a patient’s cardiovascular health by analyzing pulse and pulse oximetry waveforms in response to small perturbations. The company has received FDA and European (CE Mark) approvals for their first product, CVInsight® Patient Monitoring & Informatics System.

PECA Labs

Created out of CEO Doug Bernstein’s personal experience with congenital heart defects, PECA Labs is developing a suite of products designed to improve outcomes for children born with rare congenital heart defects. For example, the company has developed a synthetic valve conduit for pediatric right ventricular outflow tract (RVOT) reconstruction and a valve shunt for the treatment of hypoplastic left heart syndrome (HLHS).  You can read more about PECA Labs and Doug Bernstein’s story here.

Rinovum Women’s Health

Rinovum’s product, the Stork™, aids in natural fertility and conception by “supported” natural conception conducted in the privacy of a patient’s home. The product is FDA-cleared to be used without a prescription and offers a low-cost alternative to clinical treatment options.

Starr Life Sciences

Starr Life Sciences is a leader in small animal research equipment. Their products include the MouseOx Plus® pulse oximeter, the world’s first and only patented non-invasive vital signs monitor specifically designed for mice, rats and other small laboratory animals.

These companies represent just one category of the PLSG portfolio. In addition to these innovative medical device companies, we also work with innovators that are disrupting the status quo in the areas of Therapeutics, Health IT, Diagnostics, and Bio Tools. You can learn more about those companies here.

Posted in Uncategorized, PLSG News, Medical Devices, Portfolio CompaniesLeave a comment

Using Public Disclosures to Prevent Competitive Patents

Posted on August 15, 2018 by Alan West

When does disclosing a secret actually help the secret-keeper?  In the world of patents and patent protection, it can be a key strategy.

Most entrepreneurs understand that an invention must be truly novel to receive a patent.  According to the U.S. Patent and Trademark Office (uspto.gov), an invention cannot be one that has been previously “patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.”

As an example, I once worked at a company that acquired a medical device patent from a physician.  The resulting product achieved rapid market penetration, and the physician inventor received substantial royalty payments – until a competitor discovered that the inventor had described the concept to a group of physicians during a Grand Rounds at a small hospital a few days before he had filed the patent.  As a result, the patent was invalidated, the competitor began marketing a look-alike product, and the company and inventor had to deal with the rather nasty legal business of all the royalties that had been paid.

You have to be especially cautious to not disclose a patentable idea to anyone before filing a patent, unless your audience has signed non-disclosure agreements in advance.  Otherwise, it is considered to be a “public disclosure,” even if it is to one person.

You can, however, use such public disclosures to your advantage.  Let’s say you are a start-up company with a patent covering your first product.  A common defensive patent strategy is to file additional patents covering improvements and line-extensions to your original patent – a tactic known as the “picket fence.”  In this way you create a “fence” surrounding your product, making it much more difficult for competitors to get around your patent.

These new patents are all subservient to your core patent in that they are offshoots of the original and cannot be independently practiced.  As a start-up company, however, you may not have the cash to file all these new applications.  A well-financed competitor, on the other hand, may decide to file patents covering improvements to your product as an offensive strategy.

By filing enhancements to your original patent, they can create bargaining chips to use with you to negotiate a cross license, giving them the right to your original patent in exchange for you to use their patents covering product improvements.  It is a common and effective strategy, but it’s crucial to realize that it can also undermine your company’s competitive advantage.

A simple way to avoid becoming fenced in by a competitor in this way is to publish a description of the improvement in a paper or on your website.  If you are not going to file a patent on the improvement, publicly disclose the idea so no one else can patent it.  In that case your product would still be protected by your core patent.

The Intellectual Property Pyramid Assessment©, a workbook published by the Pittsburgh Life Sciences Greenhouse, will soon be available to order on Amazon. To sign up to get more details please email info@plsg.com.

Posted in Uncategorized, Business Development, Health IT, Words of Wisdom, Concentrations, Medical Devices, Diagnostics, Portfolio Companies, Therapeutics, Biotechnology ToolsLeave a comment

 PLSG Recognizes Advisory Board Member’s Selection to “30 Under 30” Class

Posted on July 24, 2018 by Delvina Morrow

 PLSG Recognizes Advisory Board Member’s Selection to “30 Under 30” Class

Carmelo Montalvo Serves on PLSG’s Under 40, Underserved Advisory Board

PITTSBURGH (July 31, 2018)—Carmelo Montalvo, a member of the Pittsburgh Life Sciences Greenhouse (PLSG) Under 40, Underserved Advisory Board, was recently named by the Pittsburgh Business Times to its 2018 “30 Under 30” Class of civic and business leaders.

 

The Pittsburgh Business Times “30 Under 30” Awards, is an annual celebration of young professionals who lead their generation and our region’s organizations and business landscape forward. In its second year, the 2018 “30 Under 30” class represents the next generation of leaders comprised of young professional across a variety of sectors who are reinventing our region for generations to come.

 

As a young professional, and transplant to Pittsburgh, Montalvo saw the opportunities of staying in the region and calling Pittsburgh home. In 2016, while completing his master’s at CMU in Healthcare Policy & Management and serving as a Defensive Line Coach for Tartan Football, Montalvo decided that he wanted to make an impact in the region by lending his talents and expertise to a life sciences startup. In 2016, Montalvo joined PLSG portfolio company Forest Devices as their Director of Operations.

 

Forest Devices created AlphaStroke, the first stroke screening device that can be used by medical personnel in any environment. Presently, 50% of stroke patients go to the wrong level of care, or a hospital without stroke care, adding an average delay of two hours. Such swift treatment eliminates delay, which can lead to negative outcomes, disabilities, and roughly $50 billion in healthcare costs in the U.S. Currently, as the Vice President of Operations for Forest Devices, Montalvo has navigated the company’s growth, and he has been instrumental in successfully closing an oversubscribed seed round of $2.3M in funding for the company’s future operations.

 

“Carmelo has played a key role in the company’s development, managing the day-to-day operations and developing standardized practices for both our product and project-management activities”. Said Matt Kessinger, CEO of Forest Devices. “Ever since joining the team, he has been willing to put his head down and get his hands dirty to accomplish goals, learn new skill sets, and promote our culture.”

 

Montalvo has provided his time, knowledge, and expertise to help move the region forward and to help advance the vibrant and growing life sciences community for entrepreneurs here in Pittsburgh. He serves as a conduit within the life sciences ecosystem through his community service, specifically within the PLSG’s Under 40, Underserved Advisory Board. As an Advisory Board member, he advises the PLSG on how it can capture and share life sciences knowledge to improve the success rates of its younger companies and entrepreneurs in obtaining capital and de-risking their programs.

 

Montalvo is a 2013 graduate of North Carolina Central University and obtained a master’s degree in Healthcare Policy & Management from Carnegie Mellon University in 2017. He was born in Brooklyn, NY and raised in New Bern, NC, and currently resides in Brookline with his wife and daughter.

 


About Forest Devices

Forest Devices is a medical device startup located in Pittsburgh, Pennsylvania. They are the creators of ALPHASTROKE, the first stroke screening device that can potentially be used by all medical personnel in any environment.  By re-purposing established technology, the team is developing a novel and objective stroke detection method. It would enable early and fast triage so stroke patients go to the appropriate level of care.  Providing a faster, safer, and cheaper alternative, over 2 million unnecessary emergency room CT scans could be averted every year. With thousands of deaths and billions in costs annually due to inadequate stroke detection, they are determined to become the new standard of care.


About the Pittsburgh Life Sciences Greenhouse (PLSG)

The Pittsburgh Life Sciences Greenhouse (PLSG) is a comprehensive life sciences economic development organization. We are dedicated to advancing life sciences in western PA by building on the region’s strengths in research, clinical care and life sciences entrepreneurship. We serve our community by providing knowledge, connection, and capital to help companies grow, create jobs, and improve the health of all humanity. For more information, please visit: www.plsg.com.

Posted in Under 40 Underserved Advisory Board, PLSG News, Portfolio CompaniesLeave a comment

Challenges and Opportunities in Treating Cognitive Disorders

Posted on May 14, 2018 by Hank Safferstein

By Hank Safferstein, Ph.D., J.D.
PLSG Executive In Residence

Cognitive disorders, such as Alzheimer’s dementia, are devastating and will put an increasing strain on our healthcare system as the population ages. As of February 2016, there were approximately 174 drugs in clinical development, with only 5 marketed therapeutics. This disparity, in large part, is due to difficulties demonstrating efficacy in clinical trials.

Efficacy can be difficult to demonstrate for two primary reasons. First, Alzheimer’s patients likely comprise a heterogeneous population where the disease can stem from disparate pathologies. Patients are segmented primarily on the presentation of symptoms. This is important because two patients with similar symptoms may have dysfunction in different pathways, meaning a therapeutic may work for one patient but not the other. When an investigational new drug is given to a specific patient population, it provides more power to a clinical trial. Second, traditional outcome measures are centered around cognition, a relatively “soft” and imprecise clinical endpoint. Cognition is considered “soft” because it naturally changes from morning to evening, from day to day, and between individuals. Additionally, patients in both the placebo and drug groups learn these cognitive tasks over the course of a clinical trial. Identification of factors that consistently report the severity of the disease across time and individuals will also provide more power to a clinical trial.

Identification of Alzheimer’s specific biomarkers can bridge these challenges. Biomarkers can provide important information on the presence and progression of the disease. An ideal biomarker can effectively link a drug’s mechanism of action to its intended effects on disease pathways. Therefore, instead of relying solely on cognitive function, drug efficacy can be based on changes in expression of molecular biomarkers. Likewise, these biomarkers can be used to segment the population based on the presence or expression of specific biomarkers instead of subjective measures of symptoms. Failure rates in Alzheimer’s clinical trials could be reduced significantly if patients were segmented based on molecular profiling.

Our challenge, to both clearly measure outcomes and segment patient populations, boils down to a core need to identify specific biomarkers of these diseases. Plasma, cerebrospinal fluid (CSF), and imaging (MRI, PET) biomarkers have the potential to improve diagnosis, stratify or otherwise segment patients, and provide measures on which to track disease progression and the effects of therapeutic and lifestyle interventions. There is a real need for the successful translation of biomarker data generated through the use of mass spectrometry, immunoassays, and imaging into patient endophenotypes. Researchers believe this will happen, but the question remains: Will regulatory agencies accept biomarkers as clinical endpoints?

The PLSG continues to conduct outreach and engage in direct involvement with life sciences innovators working to better understand and treat these cognitive disorders.

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Posted in Business Development, Portfolio CompaniesLeave a comment

Improving Consistency in Digital Health

Posted on August 7, 2017 by Jim Jordan

Digital Health is a complex system where ideas, trends, actions, and the ramifications that result, move at an ever-increasing rate of speed. In such an environment, it helps to have some level of consistency.  A set of rules, some generally agreed-to guiderails, that can keep forward progress moving while still enabling innovation and achievement.

That is why the U.S. Food and Drug Administration (FDA) recently announced establishment of a new digital health unit. Through this new group, the FDA and its Center for Devices and Radiological Health plan to ramp up medical app and device offerings, with the stated purpose of centralizing and coordinating digital health information so that there is consistency in applying policies.

Bakul Patel, associate director of digital health for the FDA, explained that the primary responsibilities of those on the project include developing software and digital health technology to assist with pre-market submissions or devices, utilize experts, and incorporate metrics that will assist with review times and submission.

This comes as welcome news for the life sciences industry, as it promises to provide some valuable structure, consistency, and direction to the burgeoning digital health marketplace, from inception of ideas through development prior to commercialization.

Creation of this digital health unit follows prior FDA actions to address this growing tech market, such as establishing guidelines for wellness apps in 2016, and cybersecurity guidelines for medical devices.

Later this year, the FDA plans to begin hiring as many as 13 full-time employees from various private sectors with hopes of having them on board by the 2018 fiscal year.

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Posted in PLSG News, Business Development, Health IT, Portfolio Companies

Harry Potter, Business Coach

Posted on July 28, 2017 by Jim Jordan

In J.K. Rowling’s collection of “Harry Potter” novels, the titular character becomes increasingly immersed in an epic showdown between the forces of good and evil in the fictional world of magic.  At the same time, he increasingly feels the need to go it alone – wanting to protect his friends and mentors from further danger.

This goes on until, at a critical moment, his friends Ron and Hermione remind Harry that he doesn’t have to do all of this himself.  They will always be there to help, the same as all of the teachers and others who have provided guidance, direction, and support all along.

Anyone who has aims for success in the business world knows the value of seeking, cultivating, respecting, and listening to respected mentors.  No single person knows every aspect of an industry, a career choice, the best way to balance personal and professional desires and obligations, and a thousand other issues.  Mentors help fill in those blanks because they’ve been through the fire.  They’ve handled the negotiations.  They’ve seen and worked through stretches when plans go awry and you have to fight to get back on track.

Mostly, mentors know you and believe in you.  They want to help you succeed, and will do all they can to bring about that result.

I faced a challenging decision some months ago regarding whether to invite an individual to a PLSG event, based on a past experience that didn’t work out so well.  My gut told me this was an important decision, and to reach out to my network.  After considering their input and perspective, the decision was made to be completely inclusive, and to keep the open nature of PLSG strong.  While I would have felt good about making that decision on my own, the validation from others I respect so highly added a level of confidence that otherwise might have been missing or diluted.

It is worth the effort to identify and court people who have blazed the trail ahead of you.  Let them know what you stand for, where you would like to go with your career and life, and ask for their help as you make your way.  It has been my experience – especially in this friendly city of Pittsburgh, where relationships and associations between people can be so easily connected – that most people would be very happy to serve as mentors and supporters.  At PLSG, we consider mentoring a key part of our mission, in fact.

After all, as that noted business coach Harry Potter learned while on his famous quest, no one has to go it alone.

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Posted in Business Development, Portfolio Companies

How Innovative Startups are Changing the Way Diseases are Diagnosed

Posted on June 5, 2015 by Hank Safferstein

Blog pic4

While the world of healthcare is one of constant change and innovation, the process of diagnosing diseases can still be difficult. The number of tests administered to any given patient and the wait time for those results can be frustrating. Each year billions of tests are administered, but leave much to be desired in terms of accuracy and patient satisfaction. There is still need for greater innovation.

Some of the most exciting diagnostic developments are coming from health startups. These small companies are able to focus on inefficiencies that may be overlooked in testing, diagnosis, monitoring, or treatment. Their efforts allow doctors to reach more accurate diagnoses and offer more effective treatments. The more this process can be improved, the better our patients’ outcomes.

Here are a few of the most important ways these startups are improving diagnostics.

 

A Personal Touch

Disease diagnoses tend to follow patterns based on the most successful treatments, but this approach can be ineffective for some patients. Advancements in medical screening technology and DNA sequencing have made it much easier to address this problem. Health startups like RedPath Integrated Pathology are poised to build on these developments to benefit patients and healthcare providers.

RedPath’s PathFinderTG tests address ambiguities in cancer diagnoses. PathFinderTG is a molecular test that reveals genetic markers and other factors that are missed by other tests. Based on patient DNA, this information helps doctors better determine whether or not a tumor is benign or malignant and recommend the most effective treatment.

 

Simplification

Some diagnostic methods subject patients to a battery of tests or put analysts through hours upon hours of manual processing of these tests. And the results might not even lead to a patient-specific treatment. Why put patients and laboratories through so much in order to reach a general diagnosis and treatment? Cernostics is changing the game by simplifying the testing process.

Cernostics’ Tissue Cypher Technology whittles that battery of tests down to one. Much like RedPath, Cernostics uses a molecular-level biopsy to better assess the cancer risk of patients with Barrett’s esophagus━one simple test with personal results. They even want to expand testing to lung, breast, and colon cancers. And with $1.4 million in their Series B startup funding round, along with prestigious academic partnerships, Cernostics is poised to make a huge impact.

 

Creativity

Sometimes the best way to innovate is to find a unique use for something seemingly mundane. Successful health tech startups, whether out of vision or necessity, have a knack for finding such uses. By using common technology in unexpected ways, even the most routine aspects of healthcare can be revolutionized.

For example, Intelomed’s CVInsight makes use of one of today’s most ubiquitous and fashionable technologies━bluetooth━to vastly improve patient monitoring. A single bluetooth sensor, worn on the patient’s forehead, gives healthcare providers real-time updates to physiologic changes. The sensors pick up the slightest unfavorable change, helping alert doctors to potential events and prevent them from ever happening.

Developments by startups like these are going to greatly improve healthcare. Ambiguities in diagnosis will be clarified, effective and appropriate treatments will be found faster, and life-threatening events will be avoided. All of this will drive down costs and boost patient satisfaction. RedPath Integrated Pathology, Cernostics, and Intelomed are all part of the incubator at the Pittsburgh Life Sciences Greenhouse, proud supporters of life science innovation.

 

 

Posted in Diagnostics, Portfolio Companies

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