Ron Rocca to Become Chief Executive Officer

SAN DIEGO, CA – May 11, 2023 – Mindera Health™, the developer of Mind.Px™, the first realization of precision medicine in psoriasis, has announced a change in its executive leadership team. The company has announced industry veteran Ron Rocca will succeed George Mahaffey as President and Chief Executive Officer. Mr. Rocca will also serve as a Director of the company. Mr. Mahaffey, who joined the company in 2020, helped lead the company’s transition from the R&D stage through the commercial launch of Mindera Health’s first test.

“On behalf of the board, I want to thank George for his valuable contributions to Mindera Health,” said Joe Cook, III, Chairman of Mindera Health and Co-Founder and Managing Director of Mountain Group Partners. “We are grateful for all that he has helped us accomplish since taking the helm and wish him the best in his future endeavors.”

“It has been my pleasure to work with such a talented team of professionals over the past three years and to assist in bringing the Mind.Px precision medicine test to market. I wish the company all the best as they expand usage of this important and innovative technology,” said Mr. Mahaffey.

“I am extremely excited to join the Mindera Health team. With a total addressable market of over $2 billion in the U.S. alone, Mind.Px has the opportunity to enable huge improvements in patient care while reducing the overall healthcare spend on this disease. In addition to psoriasis, Mindera Health’s proprietary platform also provides access to rich biomarkers that will enable us to develop precision medicine tests for a wide range of diseases,” said Mr. Rocca.

Mr. Cook went on to say, “We are very excited to have Ron join Mindera Health as we ramp up our commercial efforts with Mind.Px and advance a number of additional tests in our pipeline. Ron’s demonstrated commitment to help physicians improve patient care while driving commercial adoption and reimbursement aligns well with the mission of Mindera Health.”

Mr. Rocca brings over two decades of biotech and diagnostics industry experience, including eleven years of developing and commercializing diagnostic products for autoimmune-related diseases. His prior role was President and CEO of Exagen Inc. (NASDAQ: XGN) which commercialized a suite of testing products enabling healthcare providers to improve care for patients through the differential diagnosis, prognosis, and monitoring of systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA). Prior to Exagen, Mr. Rocca served as Vice President, Sales and Marketing, and as General Manager, at Prometheus Laboratories, Inc., a specialty pharmaceutical and diagnostic company focused on diseases in gastroenterology and oncology. He helped grow the company’s sales to $200 million-plus annually before playing an instrumental role in the $1.4 billion acquisition by Nestlé Health Science S.A. in 2011. Prior to Prometheus, Mr. Rocca was the General Manager of Alpharma Inc., a specialty pharmaceutical company. Earlier in his career, Mr. Rocca served in senior sales and marketing management positions for Elan Pharmaceuticals, Inc., a neuroscience-focused biotechnology company.

Mr. Rocca received a B.A. in Marketing and Personnel Management from Towson University. Mr. Rocca will assume his new role at Mindera Health immediately.

About Mind.Px™
Mind.Px is the flagship test of Mindera Health, designed to prospectively predict a patient’s response to expensive biologic drug classes prior to therapeutic selection and treatment. Using a scalable, minimally invasive dermal biomarker patch that captures over 7,000 biomarkers per sample along with data analytics, Mind.Px materially improves patient outcomes and significantly reduces healthcare system costs of expensive biologic treatments.

About Mindera Health™
Mindera Health is a private San Diego-area company developing and commercializing next-generation medical technology to enable a new era of skin analytics at the molecular level. Using a proprietary dermal biomarker patch, next-generation sequencing, and machine learning, Mindera Health technology generates clinically validated data to reduce healthcare system costs and improve patient outcomes. Mindera Health is a CLIA and CAP certified laboratory and has received ISO 13485:2016 certification. Find out more at www.minderahealth.com.

About Mountain Group Partners
Founded in 2002, Mountain Group Partners is a Nashville-based venture capital firm that invests in early-stage companies in the life sciences and disruptive technology sectors. The firm brings over 100 years of combined operational experience and has invested in more than 60 companies. www.mtngp.com

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[SAN DIEGO, CA – December 12, 2022]  Mindera Health has completed a $20.3 million Series A-3 financing, led by Mountain Group Partners, Rockmont Investments, and Scientific Health Development, to continue its aggressive growth strategy for the company’s groundbreaking precision medicine technology in the dermatology space.  The funds will be used to expand the commercialization of Mind.Px™, Mindera’s flagship tool which prospectively predicts patient response to expensive psoriasis biologics, as well as to continue the development of the Mindera Dermal Intelligence™ Platform. This structured data repository contains large amounts of unique clinical and biochemical data that can be analyzed using machine learning methods to reveal previously unknown correlations.

Mind.Px™ is a first-of-its-kind precision medicine dermatology solution that aligns patient, physician, and payor interests.  By predicting which biologic drugs will be effective for patients, physicians avoid trial-and-error prescription practices, payors avoid wasted spending, and most importantly, patients avoid unnecessary disease progression.  The novel Mindera technology platform uses a simple, external skin patch that extracts over 7,000 biomarkers in minutes.  Subsequent Next-Generation Sequencing of the extracted RNA allows Mindera scientists to take a genetic and transcriptomic snapshot of the patient’s skin at the exact moment of the test. In the case of Mind.Px™, this rich patient-specific data is then analyzed by proprietary machine learning algorithms to predict the appropriate psoriasis biologic drug for a patient prior to therapeutic selection and treatment.

The closing of this financing, with the support of our lead investors, is a significant validation of Mindera Health’s first-in-class technology platform and our initial solution to help patients suffering from psoriasis,” commented George Mahaffey, President and CEO of Mindera Health.

“Mindera Health is an incredibly exciting company focused on bringing about personalized medicine in dermatology with an initial focus on improving the outcomes for patients with psoriasis.  We are honored to be part of Mindera Health and passionate about helping tackle one of the most expensive and pressing challenges in the U.S. healthcare system today,” said Joe C. Cook, III, Managing Director at Mountain Group Partners.

About Mindera Health
Mindera Health is a private San Diego-based company developing and commercializing next-generation medical technology to enable a new era of skin analytics at the molecular level.  Using a proprietary dermal biomarker patch, Next-Generation Sequencing (NGS) and Machine Learning, Mindera Health technology generates clinically validated data to reduce healthcare system costs and improve patient outcomes.  Mindera Health is a CLIA and ISO 13485 certified Laboratory.  Find out more at www.minderahealth.com.

About Mountain Group Partners
Founded in 2002, Mountain Group Partners is a Nashville-based venture capital firm that invests in early-stage companies in the life sciences and disruptive technology sectors.  The firm brings over 100 years of combined operational experience and has invested in more than 60 companies.  www.mtngp.com.

About Scientific Health Development
Scientific Health Development (SHD) is a Dallas-based venture capital firm focused on early-stage investments in innovative medical device and diagnostic companies addressing large unmet needs.  Formed in 2006, SHD is motivated to improve patient outcomes and healthcare economics.  The firm is actively investing out of its fourth fund.  www.shdpartners.com.

Partnership to focus on improving patient outcomes while reducing healthcare system costs of expensive biologic therapeutics

SAN DIEGO, CA and LAKELAND, FL – January 4, 2022 – Mindera Health™ and WellDyne have entered into a definitive agreement to improve the management of psoriasis patients with moderate to severe disease using a proprietary dermal biomarker patch platform, Mind.Px™, that predicts the appropriate biologic drug class for an individual patient prior to treatment. Mindera Health is the developer of the groundbreaking Dermal Intelligence™ platform, the first realization of precision medicine in psoriasis. WellDyne is an innovative pharmacy benefit manager (PBM) with wholly-owned specialty and mail order pharmacies, a retail pharmacy network and clinical programs targeting complex conditions driving pharmacy trends today across the US. This synergistic collaboration capitalizes on the strengths of both companies and products to support improved treatment outcomes for psoriasis patients and reduce healthcare system costs of expensive biologics in the US.

Psoriasis affects nearly 3 percent of the US population, and of this group, many patients are diagnosed with moderate to severe disease which often requires treatment with expensive biologic therapeutics. The Mindera Health Mind.Px test uses a painless patch to determine an individual patient’s likelihood of response to all three major classes of biologic drugs approved for psoriasis. The patch provides physicians with a much-needed tool to predict response to expensive specialty drugs before treatment, which improves patient outcomes, reduces waste from drug cycling and creates net savings for payers.

WellDyne, which has partnered with more than 2,000 clients managing more than 3 million plan members, continuously develops easier, more accessible and lower-cost pharmacy solutions to help people live their healthiest and fullest lives.

“We are excited to partner with WellDyne and enable them to further optimize specialty drug spending for their clients by implementing Mind.Px, our groundbreaking precision medicine tool that predicts biologic drug response prior to treatment,” says George Mahaffey, President and CEO of Mindera Health. “We want to thank our strategic partner, Alva10, which specializes in connecting companies at the forefront of precision medicine with payers. Our partnership aligns the incentives of patient outcomes with payer economic utility and utilization.”

“Mind.Px delivers a best-in-class solution for optimizing specialty spend in psoriasis, and we are proud to offer it to our members,” says Nick Page, Chief Clinical Officer at WellDyne. “Our highly personalized approach to precision medicine embraces innovative, new tools that help create optimal outcomes for patients. We are developing industry-leading partnerships that leverage our deep clinical expertise for our clients in autoimmune categories and elsewhere.”

About Mind.Px™

Mind.Px is the flagship test of Mindera Health, designed to prospectively predict a patient’s response to expensive biologic drug classes prior to therapeutic selection and treatment. Using a scalable minimally invasive dermal biomarker patch that captures over 7,000 biomarkers per samples and data analytics, Mind.Px materially improves patient outcomes and significantly reduces healthcare system costs of expensive biologic treatments.

About Mindera Health™

Mindera Health is a private San Diego-area company developing and commercializing next-generation medical technology to enable a new era of skin analytics at the molecular level. Using a proprietary dermal biomarker patch, Next-Generation Sequencing and machine learning, Mindera Health technology generates clinically validated data to reduce healthcare system costs and improve patient outcomes. Mindera Health is a CLIA and CAP certified laboratory and has received ISO 13485:2016 certification. Find out more at www.minderahealth.com.

About WellDyne

For more than 25 years, WellDyne has leveraged its deep clinical expertise to achieve better outcomes and reduce pharmacy trend. Knowing that medications are the safest, easiest and lowest-cost treatments to help people live their best lives, the company believes a smarter approach to the delivery of PBM services unleashes the full power of medications to reduce future healthcare costs. Read more at www.welldyne.com.

 

 

Observational studies leverage machine learning to create Mind.Px^TM, a test that prospectively predicts biologic class response for individual psoriasis patients with high Positive Predictive Values (PPV)

SAN DIEGO, CA – November 16, 2021 – Mindera Health™, developers of the ground-breaking Dermal Intelligence™ platform that is the first realization of personalized medicine in psoriasis,  has announced the publication of data and positive results from the observational STAMP-1 and STAMP-2 studies. These studies combined baseline dermal genetic testing using the Mind.Px™ platform to capture and analyze the whole transcriptome combined with proprietary artificial intelligence bioinformatics to develop predictive algorithms.

In 2019, the American Academy of Dermatology and the National Psoriasis Foundation published joint guidelines addressing care for the management and treatment of psoriasis with biologics. Amongst the many recommendations, the guidelines conclude with an important statement: “There is also an important need to identify biomarkers that can potentially predict the appropriate biologic agent for individual patients.”¹ The published data and results from the STAMP studies provide this information.

A total of 242 psoriasis patients were enrolled across these two studies, and biologic response predictive classifiers were developed and validated for each of the three biologic drug classes. Positive Predictive Values (PPV) for the classifiers (IL-23i, IL-17i and TNFai) were 93.1 percent, 92.3 percent and 85.7 percent, respectively, and balanced accuracy for all three was 69 percent.

Importantly, over the entire cohort, 99.5 percent of patients were predicted to respond to at least one drug class using a well-adopted clinical measure (PASI 75) at week 12, validating the broad efficacy of biologic drugs in the treatment of psoriasis.

“Applying machine learning to the transcriptomes collected during the STAMP studies has created a powerful predictive  tool that can provide guidance to dermatologists in choosing the right biologic for a psoriasis patient the first time,” said Tobin Dickerson, Chief Scientific Officer and Co-Founder of Mindera Health. “This study represents a critical milestone in bringing precision medicine to psoriasis patients.”

“The introduction of biologics to the treatment algorithm revolutionized psoriasis treatment, yet developing reliable data and tools for physicians to confidently prescribe the proper biologic therapy for an individual psoriasis patient to increase response rate is a significant unmet medical need,” said George Mahaffey, President and CEO of Mindera Health. “These positive results from the STAMP studies address this need to improve patient outcomes while significantly lowering healthcare system costs by reducing payer wasted spend and increasing net savings.”

About Mind.Px

Mind.Px is the flagship test of Mindera Health. The Mindera Health platform uses a dermal biomarker patch that takes only minutes to extract vast transcriptomic information. Subsequent Next-Generation Sequencing of the extracted RNA allows Mindera Health scientists to take a genetic and transcriptomic snapshot of the skin. This rich patient-specific data set is then analyzed by machine learning algorithms to predict the appropriate biologic drug for an individual patient prior to therapeutic selection and treatment.

The ability to collect patient data at scale results in a powerful platform that unlocks cost savings for healthcare systems, particularly when applied to the prediction of response to hyper-expensive treatments. Biomarkers captured using the Mindera Health platform include DNA, RNA, protein, and small molecules.

About Mindera Health

Mindera Health is a private San Diego-area company developing and commercializing next-generation medical technology to enable a new era of skin analytics at the molecular level.  Using a proprietary dermal biomarker patch, Next-Generation Sequencing (NGS) and machine learning, Mindera Health technology generates clinically validated data to reduce healthcare system costs and improve patient outcomes.  Mindera Health is a CLIA and CAP certified Laboratory and has received ISO 13485:2016 certification.  Find out more at www.minderahealth.com.

Mind.Px brings personalized medicine to psoriasis patients by improving pre-treatment biologic drug class choice with >90% positive predictive value

SAN DIEGO – October 21, 2021 – Mindera Health, developers of the ground-breaking Dermal Intelligence™ platform that is the first realization of personalized medicine in psoriasis, announced the enrollment of the first patient in the MATCH Study. MATCH is a 16-week randomized clinical utility evaluation of the pre-treatment impact of Mind.Px on biologic drug response rates in patients suffering from psoriasis. The 200 patient study will include approximately 20 sites throughout the US.

According to a recent publication reporting data from the largest independent psoriasis registry (CorEvitas),[1] real-world patient response rates to hyper-expensive biologics were observed to be approximately 52%. These low response rates often lead to switching of therapies and massive wasted healthcare spending. With Mind.Px, physicians now have a predictive test to improve management of psoriasis patients and can prescribe biologic drugs with more confidence that a patient will achieve a desired outcome. Mind.Px produces a result with >90% positive predictive value (PPV), meaning that when Mind.Px predicts a patient will respond to a specific drug class, they do respond >90% of the time.

“Accessing and using an individual psoriasis patient’s baseline genetic biomarkers to prospectively predict that patient’s response to specific drugs and drug classes has been needed for many years”, says James Wang, MD, MBA, FAAD, Founder Metropolis Dermatology. “Being the dermatologist that enrolled the first patient into this important MATCH Study is exciting and we look forward to reporting the results in the near future.”

About Mind.Px

Mind.Px is the flagship test of Mindera Health. The Mindera Health platform uses a dermal biomarker patch that takes only minutes to extract vast transcriptomic information. Subsequent Next-Generation Sequencing of the extracted RNA allows Mindera Health scientists to take a genetic and transcriptomic snapshot of the skin. This rich patient-specific data set is then analyzed by machine learning algorithms to predict the appropriate biologic drug for an individual patient prior to therapeutic selection and treatment.

The ability to collect patient molecular data at scale results in a powerful platform that unlocks cost savings for healthcare systems, particularly when applied to the prediction of response to hyper-expensive treatments. Biomarkers captured using the Mindera platform may include DNA, RNA, protein, and small molecules.

 About Mindera Health

Mindera Health is a private San Diego-area company developing and commercializing next-generation medical technology to enable a new era of skin analytics at the molecular level.  Using a proprietary dermal biomarker patch, Next-Generation Sequencing (NGS) and Machine Learning, Mindera Health technology generates clinically validated data to reduce healthcare system costs and improve patient outcomes.  Mindera is a CLIA and CAP certified Laboratory and has received ISO 13485:2016 certification.  Find out more at www.minderahealth.com.

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¹ Enos CW, et al. Psoriasis Severity, Comorbidities, and Treatment Response Differ among Geographic Regions in the United States. JID Innovations 2021; 1:100025.

Combining Machine Learning with Next-Generation Sequencing creates Dermal Intelligence™: actionable information for payers, providers and patients to improve health outcomes and reduce healthcare spending.

(SAN DIEGO, CA – October 5, 2021) Mindera Corporation, developers of the groundbreaking Mind.Px™ – the first realization of truly personalized medicine in psoriasis – has changed its name to Mindera Health to better reflect the company’s data-driven precision medicine technology platform.

At the forefront of personalized medicine, the Mindera Health platform uses a patented, minimally invasive device to collect genetic biomarkers that correlate a patient’s transcriptome with that patient’s likely response to biologic treatments. By combining these genetic markers with machine learning, the Mindera Health platform helps physicians confidently choose what class of drug will work for an individual patient, the first time, eliminating wasted spending and improving patient outcomes.

The company’s first product, Mind.Px™, is focused on an uncharted territory in personalized medicine – dermatology – and the treatment of psoriasis, which afflicts 8 million individuals annually and represents a $25 billion market. Currently, nearly 48% of biologics failed in an average of 242 days, most often due to loss of efficacy,[1] and leading organizations including the American Academy of Dermatology have specifically called out the need to “identify biomarkers that can potentially predict the appropriate biologic agent for individual patients.”[2]

The company intends to use its patented technology platform using machine learning data-driven analytics for myriad indications and broad applications beyond dermatology in the future.

“Mindera Health is at the forefront of precision medicine, and our name change reflects our commitment to improving health and outcomes,” said George Mahaffey, CEO of Mindera Health. “This is a total paradigm shift for dermatology – we can deliver critical information to prospectively determine which biologic treatments could work best for individual patients using data collected from that patient – truly personalized medicine, here, today.”

About Mind.Px

Mind.Px is the flagship test of Mindera Health.  The platform uses a dermal biomarker patch that takes only minutes to extract vast transcriptomic information. Subsequent Next-Generation Sequencing of the extracted RNA allows Mindera Health scientists to take a genetic and transcriptomic snapshot of the skin. This rich patient-specific data set is then analyzed by machine learning algorithms to predict the appropriate biologic drug for an individual patient prior to therapeutic selection and treatment. The ability to collect patient data at scale results in a powerful platform that unlocks cost savings for healthcare systems, particularly when applied to the prediction of response to hyper-expensive treatments. Biomarkers captured using the Mindera Health platform include DNA, RNA, protein, and small molecules.

About Mindera Health

Mindera Health is a private San Diego-area company developing and commercializing next-generation medical technology to enable a new era of skin analytics at the molecular level.  Using a proprietary dermal biomarker patch, Next-Generation Sequencing (NGS) and Machine Learning, Mindera Health technology generates clinically validated data to reduce healthcare system costs and improve patient outcomes.  Mindera Health is a CLIA and CAP certified Laboratory and has received ISO 13485:2016 certification.  Find out more at www.minderahealth.com.

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¹ Levin AA, Gottlieb AB, Au SC. A comparison of psoriasis drug failure rates and reasons for discontinuation in biologics vs conventional systemic therapies. J Drugs Dermatol. 2014 Jul;13(7):848-53. PMID: 25007369.

² Joint AAD-NPR guidelines of care for the management and treatment of psoriasis with biologics.