Emerald Health Pharmaceuticals, Inc.

SALT LAKE CITY--( BUSINESS WIRE )--Enhanced Healthcare Partners (“EHP”), a leading private equity firm specializing in transformative, middle-market healthcare businesses, is pleased to announce its portfolio company, Vytalize Health, has acquired a controlling stake in physician-led Independent Physician Association of New York (“IPA NY”), following its recent $100 million equity and debt capital raise led by EHP. Headquartered in Suffolk County, IPA NY is one of the largest multi-specialty IPAs in the country, with more than 3,000 providers. Vytalize is a leading value-based care platform created to help independent physicians and practices improve patient care and lower costs through evidence-based, data-driven medicine. Rooted in an existing foundation of long-term partnership between the two organizations, Vytalize took a controlling interest in IPA NY’s management company, Practice Management of America (“PMA”), which provides clinical care management, care coordination and administrative services across more than 1,000 locations. EHP made its initial investment in Vytalize in March 2022. “ One year into our partnership, Vytalize has seen exceptional growth in its care delivery infrastructure and geographical presence,” commented EHP General Partner Samarth Chandra. “ EHP recognizes that additional capital and strategic M&A will further Vytalize’s momentum and drive sustainable relationships for its care delivery network — ultimately bettering the healthcare experience and empowering patients with their health outcomes.” Adding IPA NY to the Vytalize platform aligns with the company’s mission to strengthen value-based primary care practices and transform the healthcare experience. “ Both Vytalize and IPA NY have strong market presence within the Tri-State area and share a commitment to supporting independent physicians and patients,” said Vytalize Co-Founder and CEO Faris Ghawi. “ IPA NY’s provider base offers a great opportunity for Vytalize to grow its core business and expand into commercial and Medicare Advantage.” EHP led Vytalize’s $100 million financing round with debt capital support from Monroe Capital. ABOUT ENHANCED HEALTHCARE PARTNERS Enhanced Healthcare Partners is a leading healthcare-focused private equity firm dedicated to making minority and majority investments in founder and entrepreneur-led middle-market companies. The EHP team has managed approximately $1 billion in equity capital and is comprised of professionals with deep healthcare, operations, consulting and investment management experience. The firm seeks to invest in companies between $50-$250 million in enterprise value, driving deep partnerships with management and founders to catalyze growth and build great organizations. For more information, visit www.enhancedhealthcare.com . ABOUT VYTALIZE HEALTH Vytalize Health is a risk-bearing provider enablement platform addressing the healthcare industry’s biggest challenges with its cutting-edge value-based care delivery system. Vytalize partners with more than 3,000 leading providers to improve the quality of care through evidence-based medicine and a patient experience rooted in kindness. By delivering the right data at the right time in the workflow to physicians and their staff, Vytalize makes its partners more efficient and effective, allowing them to focus on proactive, personalized medicine to improve the value of care and lower costs. Learn more at www.vytalizehealth.com . ABOUT MONROE CAPITAL Monroe Capital LLC is a premier boutique asset management firm specializing in private credit markets across various strategies including, direct lending, asset-based lending, specialty finance, opportunistic and structured credit, and equity. Since 2004, the firm has been successfully providing capital solutions to clients in the U.S. and Canada. Monroe prides itself on being a value-added and user-friendly partner to business owners, management, and both private equity and independent sponsors. Monroe’s platform offers a wide variety of investment products for both institutional and high net worth investors with a focus on generating high quality “alpha” returns irrespective of business or economic cycles.

SAN DIEGO, CA, Jan. 11, 2023 (GLOBE NEWSWIRE) -- Emerald Health Pharmaceuticals Inc. (“EHP” or the “Company”), a clinical-stage biopharmaceutical company developing a new class of medicines to treat neurodegenerative, autoimmune and other diseases, has received a positive safety review following a pre-specified interim analysis by the Safety Review Committee (“SRC”) of its Phase 2a study of EHP-101 for systemic sclerosis (“SSc”). The SRC has recommended that the trial continue without modification. EHP expects to report interim results from the study in early 2023. The SRC is comprised of two physicians, one independent and the other the principal investigator in the trial. The SRC has the ability to recommend that the trial continues at the same dose or at a lower dose, that it escalates to a higher dose, or that the study be terminated altogether due to safety concerns. The SRC evaluated the blinded safety data from all patients enrolled in cohorts 1 and 2 at least up to one month post first dose, at 25 mg daily and 25 mg twice daily (50mg), respectively. They determined that EHP-101 was well-tolerated, with no drug-related serious adverse events and only mild related adverse events reported. The pharmacokinetic analysis of plasma samples over the course of the 3-month treatment did not show apparent drug accumulation in patients’ blood. “We are pleased that the safety analysis of the first two cohorts of this Phase 2a study of EHP-101 in systemic sclerosis has confirmed a positive safety pro the drug to date, consistent with the safety pro observed in our large Phase 1 study,” said Alain Rolland, Pharm.D., Ph.D., COO of EHP. “EHP-101’s mechanism of action offers the prospect of important therapeutic effects for patients. We look forward to reporting the full interim analysis of this study in early 2023. We are working to secure the funds necessary to continue the next phase of this Phase 2a study.” The Company’s lead product candidate, EHP-101, is an oral formulation of a patented new molecule. This SSc Phase 2a trial is a double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of EHP-101 in patients with SSc. SSc is a disease characterized by rapid fibrosis of the skin and internal organs. EHP has completed the first two cohorts, each with nine SSc patients, administering two doses either once daily or twice daily. The treatment lasted for 12 weeks, with a 4-week follow-up. Further details about the study design can be found on ClinicalTrials.gov: NCT04166552. EHP has obtained clearance from the FDA to amend the study protocol to increase the size of the higher-dose cohorts 3 and 4 from a total of 18 to a total of 48 subjects and increase the treatment duration from 12 weeks to 24 weeks. The Company applied for this amendment to create a pathway to possibly advance directly into a Phase 3 clinical trial of EHP-101 in patients suffering from SSc once the Phase 2a trial is completed, rather than first conducting a Phase 2b before continuing to a Phase 3 trial. About EHP-101 EHP-101 is an oral formulation of VCE-004.8, a first-in-class activator of the subunit B55alpha of the protein phosphatase PP2A that is implicated in the hypoxia inducible factor pathway. It also provides dual peroxisome proliferator-activated receptor gamma modulation and cannabinoid receptor type 2 agonist activity. Those receptors are important therapeutic targets for SSc, a disorder with various etiologies. EHP has received Orphan Drug Designation for EHP-101 in SSc in both the US and EU and Fast Track Designation for systemic sclerosis in the US. About Systemic Sclerosis SSc, a severe form of scleroderma, is a rare and chronic autoimmune disease, causing fibrosis of the skin and internal organs, including small blood vessel damage in the skin and multiple other organs in the body such as lung, heart, kidneys, musculoskeletal system and the gastrointestinal tract. The tissues of these organs become hard and fibrous, causing them to function less efficiently. While the symptoms of SSc vary for each person, it can be life-threatening, depending on which parts of the body are affected and the extent of the disease. SSc is subclassified into diffuse cutaneous SSc (dcSSc) or limited cutaneous SSc (lcSSc) based on the extent of skin involvement. Patients with dcSSc have more areas involved, and measurements of the effects of treatment have been validated by international clinical trial experts for this subset of SSc patients. The disease is more common in adults, with approximately 80,000-100,000 people affected in the US. There are no approved treatments specific to SSc. Current therapies for this disease include mainly drugs that suppress the immune system, are limited in efficacy, and sometimes present toxicities. New treatments will be critical to help reduce the symptoms of SSc and prevent further damage to the body. About Emerald Health Pharmaceuticals Inc. EHP is developing novel product candidates for the treatment of CNS, autoimmune, and other diseases with unmet medical needs. The Company has two families of patented new chemical entities that it has created through rational drug design to affect validated receptors and pathways in the body which are pertinent to targeted diseases. Its first drug product candidate, EHP-101, is in a Phase 2a study for the treatment of SSc, a severe form of scleroderma, and has met regulatory requirements to start a Phase II study for multiple sclerosis. Its second product candidate, EHP-102, is in preclinical development and is focused on treating Parkinson’s disease and Huntington’s disease. EHP-101 has received Orphan Drug Designation in the US and EU, as well as Fast-Track status by the US FDA for systemic sclerosis. EHP-102 has received Orphan Drug Designation in the US and EU for Huntington’s disease. For more information, visit or contact info@emeraldpharma.com. Forward Looking Statements To the extent statements contained in this news release are not descriptions of historical facts regarding Emerald Health Pharmaceuticals Inc. they should be considered "forward-looking statements," as described in the private securities litigation reform act of 1995, that reflect management's current beliefs and expectations. You can identify forward-looking statements by words such as "anticipate," "believe," "could," "estimate," "expect," "forecast," "goal," "hope," "hypothesis," "intend," "may," "plan," "potential," "predict," "project," "should," "strategy," "will," "would," or the negative of those terms, and similar expressions that convey uncertainty of future events or outcomes. Forward-looking statements contained in this news release include, but are not limited to, statements regarding: (i) the success and timing of our product development activities and clinical trials; (ii) our ability to develop our product candidates; (iii) our plans to research, discover, evaluate and develop additional potential product, technology and business candidates and opportunities; (iv) the anticipated timing of clinical data availability; (v) our ability to meet our milestones; and (vi) our expectations regarding our ability to obtain and maintain intellectual property protection. Forward-looking statements are subject to known and unknown factors, risks and uncertainties that may cause actual results to differ materially from those expressed or implied by such forward-looking statements. Undue reliance should not be placed on forward-looking statements. We undertake no obligation to update any forward-looking statements. Emerald Health Pharmaceuticals' investigational drug products have not been approved or cleared by the FDA

NEW YORK, June 23, 2022 /PRNewswire/ -- As per Zion Market Research study, The global scleroderma diagnostics and therapeutics market was approximately USD 2232.5 million in 2021 and is anticipated to reach nearly USD 4127.6 million by 2028, with a compound annual growth rate (CAGR) of about 9.2 percent over the forecast period. Key Industry Insights & Finding of the Scleroderma Diagnostics and Therapeutics Market Reports: As per the analysis shared by our research analyst, the Scleroderma Diagnostics and Therapeutics Market is expected to grow annually at a CAGR of around 9.2 % (2022-2028). Through the primary research, it was established that the Scleroderma Diagnostics and Therapeutics Market was valued approximately USD 2232.5 Million in 2021 and is projected to reach to roughly USD 4127.6 Million by 2028. Major factors such as favorable reimbursement policies, heavy investment in R&D and drug development, and well-established healthcare infrastructure are boosting the growth of the market in this region. The growing prevalence of the disease and technological advancement in the field of medical devices are also propelling the growth of the market in this region. Europe is anticipated to hold the second-most position in the market owing to an increase in initiatives and proactive awareness regarding the diagnostics for scleroderma. Zion Market Research published the latest report titled as "Scleroderma Diagnostics And Therapeutics Market By Diagnostic Test Type (Blood Tests, Imaging Techniques, Skin Biopsy, Pulmonary Function Tests, And Electrocardiogram & Echocardiogram), By Indication (Systemic Scleroderma And Localized Scleroderma), By Drug Class (Prostacyclin Analogues, Endothelin Receptor Antagonists, Phosphodiesterase 5 Inhibitors – PHA, Immunosuppressors, Analgesics, Calcium Channel Blockers, And Others), And By Region – Global And Regional Industry Overview, Market Intelligence, Comprehensive Analysis, Historical Data, And Forecasts 2022 – 2028." into their research database. Scleroderma Diagnostics and Therapeutics Market : Overview Scleroderma is an autoimmune disease wherein healthy tissue is substituted with thick, dense, fibrous tissue. It is a chronic, albeit rare, condition. The immune system normally aids in the body's defense against sickness and infection. The immune system in scleroderma patients causes other cells to create excessive collagen. This excess collagen builds up in the organs and skin, causing hardness and thickness similar to the process of scarring. While scleroderma has no cure, therapy can help to alleviate symptoms, reduce progression, and enhance the quality of life. Scleroderma can impact several other body parts, such as the gastrointestinal system, joints, muscles, blood vessels, kidneys, and lungs, in addition to the skin. Scleroderma can be life-threatening in its most severe forms. Get a Free Sample Report with All Related Graphs & Charts (with COVID 19 Impact Analysis): Our Free Sample Report Includes: 2022 Updated Report Introduction, Overview, and In-depth industry analysis COVID-19 Pandemic Outbreak Impact Analysis Included 180 + Pages Research Report (Inclusion of Updated Research) Provide Chapter-wise guidance on Request 2022 Updated Regional Analysis with Graphical Representation of Size, Share & Trends Includes Updated List of tables & figures Updated Report Includes Top Market Players with their Business Strategy, Sales Volume, and Revenue Analysis Zion Market Research methodology Industry Dynamics: Scleroderma Diagnostics and Therapeutics Market : Growth Drivers Growing prevalence of scleroderma is fostering the growth of the market. In developed as well as developing countries, the prevalence of scleroderma is growing at a rapid rate. This condition affects between 75,000 to 100,000 persons in the United States, the majority of whom are females between the ages of 30 to 50. Twins and family members of people with scleroderma or even other autoimmune connective tissue illnesses like lupus are at an increased risk of developing the condition. Scleroderma can affect children, although the condition affects them differently than it does adults. Such a huge burden of disease has led to increase in awareness and need for diagnosis of the disease. This is ultimately driving the market growth. In addition to this, favorable reimbursement policies, well-developed health infrastructure, and growing necessity for developed diagnostic techniques are some of the key factors that are boosting the growth of the market for scleroderma diagnostics and therapeutics. Scleroderma Diagnostics and Therapeutics Market : Restraints High cost associated with scleroderma diagnostic and treatment is likely to hamper the market growth. The multiorgan nature of systemic sclerosis necessitates long-term monitoring and a variety of approaches to patient management. As a result, it's no surprise that systemic sclerosis is one of the most expensive rheumatic illnesses, with patients using more healthcare dollars per year than their age and sex-matched colleagues with inflammatory myopathies, psoriatic arthritis, and/or RA. Additionally, some of the direct costs for patients with systemic sclerosis include acute-care hospitalization, assistive devices, medications, diagnostic tests as well as visits to healthcare professionals. Thus, the financial cost of systemic sclerosis is substantial, and disease & health conditions have a significant influence on the economic burden thereby impeding the growth of the global scleroderma diagnostics and therapeutics market. In addition to this, factors such as low penetration of the market in underdeveloped countries, adverse effects associated with the drugs, and low spending power in rural areas are also hampering the market growth. Directly Purchase a Copy of the Report @ Global Scleroderma Diagnostics and Therapeutics Market : Opportunities Growing focus on development of innovative methods is estimated to drive the market during the forecast period. Systemic sclerosis is a multifaceted autoimmune disease with a wide range of symptoms and degrees of internal organ damage. All consequences have a substantial influence on the patient's quality of life as well as morbidity and death rates. As a result, there is a growing interest in novel ways of assessing, diagnosing, and monitoring organ involvement. In addition to this, there is an increase in investment in R&D activities by major players for the development of new and effective treatments. Major players are also focusing on the completion of clinical trials for the drugs and looking forward to the approval of the drug for the treatment of scleroderma. All such factors coupled with technological advancements including the implementation of artificial intelligence and internet of things in the field of medical devices are anticipated to generate numerous opportunities for the growth of the global scleroderma diagnostics and therapeutics market during the forecast period. Global Scleroderma Diagnostics and Therapeutics Market : Challenges Strict regulations for the approval of drugs and diagnostic devices for scleroderma may act as a challenge to the market growth. By far there are very less approved drugs for the treatment of scleroderma. Scleroderma is a rare disease and its diagnosis is also challenging. The vague clinical presentation of scleroderma might make diagnosis difficult, resulting in a delayed diagnosis. This also interferes in the development of drugs that can be effectively used to treat the disease. The lack of sufficient data on the efficacy and safety of the drugs leads to the failure of clinical trials. The regulatory bodies across different countries have imposed strict regulations for the approval of drugs and diagnostic devices in order to have appropriate diagnosis and treatment of the disease. This may act as a major challenge to the growth of the market. Global Scleroderma Diagnostics and Therapeutics Market : Segmentation The global scleroderma diagnostic and therapeutics market is categorized based on diagnostic test type, indication, drug class, and region. The diagnostic test type segment comprises blood tests, imaging techniques, skin biopsy, pulmonary function tests, and electrocardiogram & echocardiogram. Based on the indication, the global market is bifurcated into systemic scleroderma and localized scleroderma. The drug class segment is classified into prostacyclin analogues, endothelin receptor antagonists, phosphodiesterase 5 inhibitors – PHA, immunosuppressors, analgesics, calcium channel blockers, and others. Get More Insight before [email protected] : List of Key Players of Scleroderma Diagnostics and Therapeutics Market : Bayer AG; Boehringer Ingelheim International GmbH arGentis Pharmaceuticals LLC Celgene Corp. Bristol-Myers Squibb Company F. Hoffman La-Roche Ltd. Corbus Pharmaceuticals Holdings Seattle Genetics Inc. Kadmon Holdings Inc. Emerald Health Pharmaceuticals Prometic Life Sciences Inc. Key questions answered in this report: What are the growth rate forecast and market size for Scleroderma Diagnostics and Therapeutics Market ? What are the key driving factors propelling the Scleroderma Diagnostics and Therapeutics Market forward? What are the most important companies in the Scleroderma Diagnostics and Therapeutics Market Industry? What segments does the Scleroderma Diagnostics and Therapeutics Market cover? How can I receive a free copy of the Scleroderma Diagnostics and Therapeutics Market sample report and company profiles? Report Scope: Free Brochure: Recent Developments In March 2021, Roche received approval for Actemra®/RoActemra® (tocilizumab) subcutaneous injection from the US Food and Drug Administration (FDA) for decreasing the rate of drop in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD), a chronic condition with few treatment options. The FDA has approved Actemra/RoActemra as the first biologic medication for the treatment of the condition. In April 2020, Boehringer Ingelheim received approval from the European Commission for nintedanib for the treatment of people with systemic sclerosis-associated interstitial lung disease (SSc-ILD). Regional Dominance: North America is estimated to rule the market for scleroderma diagnostics and therapeutics. Among the regions, North America is expected to dominate the global scleroderma diagnostics and therapeutics market. Major factors such as favorable reimbursement policies, heavy investment in R&D and drug development, and well-established healthcare infrastructure are boosting the growth of the market in this region. Additionally, the growing prevalence of the disease and technological advancement in the field of medical devices are also propelling the growth of the market in this region. Europe is anticipated to hold the second-most position in the market owing to an increase in initiatives and proactive awareness regarding the diagnostics for scleroderma. On the other hand, the market in Asia Pacific is likely to grow at the highest CAGR during the forecast period. This is majorly due to the wide and easy availability of generic & biosimilar immunosuppressants for the treatment of scleroderma. Global Scleroderma Diagnostics and Therapeutics Market is segmented as follows: Scleroderma Diagnostics and Therapeutics Market : By Diagnostic Test Type Outlook (2022-2028) Blood Tests Imaging Techniques Skin Biopsy Pulmonary Function Tests Electrocardiogram & Echocardiogram Scleroderma Diagnostics and Therapeutics Market : By Indication Outlook (2022-2028) Systemic Scleroderma Localized Scleroderma Scleroderma Diagnostics and Therapeutics Market : By Drug Class Outlook (2022-2028) Prostacyclin Analogues Endothelin Receptor Antagonists Phosphodiesterase 5 Inhibitors – PHA Immunosuppressors Analgesics Calcium Channel Blockers Others Scleroderma Diagnostics and Therapeutics Market : By Region Outlook (2022-2028) North America The U.S. Canada Europe France The UK Spain Germany Italy Rest of Europe Asia Pacific China Japan India South Korea Southeast Asia Rest of Asia Pacific Latin America Brazil Mexico Rest of Latin America Middle East & Africa GCC South Africa Rest of Middle East & Africa Press Release For Scleroderma Diagnostics and Therapeutics Market : Browse Other Related Research Reports from Zion Market Research Orthopedic Soft Tissue Repair Market - Global Industry Analysis : The global Orthopedic Soft Tissue Repair Market accrued earnings worth approximately 5.7 (USD Billion) in 2020 and is predicted to gain revenue of about 11.2 (USD Billion) by 2028, is set to record a CAGR of nearly 6.4% over the period from 2021 to 2028. 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