Based on findings from a study published in the National Library of Medicine analyzing prescribing trends in the United States, it was revealed that around 2.9% of men aged over 40 years and 3.75% of men aged over 60 years have received prescriptions for various forms of Testosterone Replacement Therapy. Given the estimated male population in the US stands at approximately 166.7 million, this translates to a sizable market of approximately 5 million men currently undergoing Testosterone Replacement Therapy in some capacity. This data underscores the significant demand and potential growth opportunities within the Testosterone Replacement Therapy market segment.
Moreover, the debut of oral testosterone therapy not only signifies a pivotal advancement but also unlocks a lucrative avenue within the market. Providing an alternative to injectable Testosterone Replacement Therapy, oral therapy caters to the needs of individuals who harbor reservations or reluctance towards injections. This segment, comprising those with aversions to needles, constitutes a significant portion of the demographic landscape. Consequently, it underscores the considerable potential and promising trajectory of oral testosterone therapy, positioning it as a compelling solution poised for substantial growth and adoption.
PRIME marks a significant stride into an untapped vertical boasting immense market prospects and minimal consumer competition, aligning seamlessly with MangoRx’s steadfast commitment to pioneering innovative pharmaceutical solutions aimed at empowering men to attain peak performance across all facets of life. Leveraging its well-established marketing channels and robust telemedicine infrastructure, MangoRx is poised for swift and effective dissemination of PRIME to patients nationwide. Each order will undergo a thorough review and, upon approval, will be promptly processed and discreetly dispatched through MangoRx’s URAC-accredited mail-order partner pharmacy, ensuring seamless delivery directly to the patient’s doorstep. This strategic approach not only underscores MangoRx’s dedication to accessibility and convenience but also solidifies its position as a trailblazer in the realm of men’s health solutions.
Jacob Cohen, MangoRx’s Co-Founder and CEO, noted, “We firmly believe that between the convenience and non-invasive factor of taking PRIME orally and the reduced side effects that come with it as opposed to traditional injectable TRT, MangoRx is very well positioned to grab a significant piece of the current market share for men experiencing Low-T. As we believe PRIME’s oral delivery TRT treatment is a true game-changer, MangoRx will be seeking to engage popular social media influencers as well as high-profile celebrities and athletes to assist us as we launch PRIME into the marketplace.”
Overall, the official launch of ‘PRIME’ by MangoRx marks a significant milestone in the Testosterone Replacement Therapy Market. With its innovative oral solution and commitment to accessibility through telemedicine, PRIME promises to revolutionize Testosterone Replacement Therapy treatment, offering patients a convenient, discreet, and effective option to address low testosterone levels. By combining advanced pharmaceutical technology with patient-centric care, MangoRx is poised to enhance the well-being and quality of life of countless individuals seeking optimized health and vitality.
Setpoint Medical Granted FDA Breakthrough Device Designation for Neuroimmune Modulation Platform in Treating Multiple Sclerosis
On March 13, 2024, SetPoint Medical made a significant stride in healthcare innovation with the announcement of receiving Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). This designation marks a pivotal advancement in the realm of medical technology, particularly for individuals affected with Relapsing-Remitting Multiple Sclerosis (RRMS).
SetPoint Medical’s breakthrough neuroimmune modulation platform offers a novel approach to addressing the complexities of RRMS. By gaining the FDA’s Breakthrough Device Designation, SetPoint now stands poised for enhanced collaboration and streamlined regulatory processes with the FDA. This designation not only facilitates interactive communication but also ensures priority review of SetPoint’s technology, expediting its journey toward FDA approval.
Moreover, the Breakthrough Device Designation holds promising implications beyond regulatory pathways. It paves the way for potential reimbursement strategies, thereby fostering improved patient access to SetPoint’s groundbreaking solution upon its FDA clearance. SetPoint’s commitment to transforming the landscape of RRMS treatment underscores the significance of this milestone, promising hope and progress for individuals battling this challenging condition.
During an outpatient procedure, SetPoint’s integrated neurostimulation device is implanted into the vagus nerve through a minor incision made on the left side of the neck. Subsequently, the device is configured to administer therapy automatically according to a predetermined schedule. This involves stimulating the vagus nerve once daily to initiate the inflammatory reflex, thereby inducing a systemic immune-restorative response.
In the United States, close to one million individuals living with Multiple Sclerosis, an autoimmune ailment characterized by the deterioration of the myelin sheath, the protective covering enveloping and safeguarding nerve fibers. This erosion disrupts the transmission of signals to and from the brain, triggering neurodegeneration and unleashing a cascade of incapacitating symptoms including visual impairment, mobility challenges, sensory disruptions, pain, cognitive impairment, and overwhelming fatigue.
Currently, there exists no definitive cure for Multiple Sclerosis. While currently approved medications may slow down the progression of the disease and occasionally alleviate certain symptoms, none of these treatments directly target the fundamental issue underlying Multiple Sclerosis —the deterioration of the myelin sheath.
In 2020, the FDA bestowed Breakthrough Device Designation upon SetPoint’s apparatus tailored for addressing rheumatoid arthritis (RA). Presently, SetPoint is in the process of assessing its investigational platform technology through the pivotal human clinical trial known as the RESET-RA study, aimed at treating adults contending with moderate-to-severe RA. This device harnesses targeted vagus nerve stimulation to initiate innate anti-inflammatory and immune-restorative pathways, offering a promising avenue for combatting inflammation-driven autoimmune disorders.
“Great strides have been made over the past decade to develop drugs that can attenuate disease activity and slow the rate of development of new lesions in MS,” said Shiv Saidha, M.B.B.Ch., Professor of Neurology at Johns Hopkins University. “However, these drugs do not completely stop the development of new lesions, nor do they promote repair (remyelination) of existing lesions and damaged tissue. There is an urgent unmet medical need for therapies that can promote protection and functional restoration of damaged axons through remyelination in patients, and SetPoint’s therapeutic approach could offer new hope to people living with this chronic debilitating condition.”
“This significant milestone highlights the platform potential of SetPoint’s device and therapeutic approach for the treatment of multiple chronic conditions,” said Murthy V. Simhambhatla, Ph.D., Chief Executive Officer of SetPoint Medical. “As next steps, we look forward to working collaboratively with the FDA to initiate the first-of-its-kind clinical trial to investigate our device for people living with RRMS.”
In conclusion, SetPoint Medical’s FDA Breakthrough Device Designation for its Neuroimmune Modulation Platform in Treating Multiple Sclerosis not only alleviates the burden of limited treatment options for patients but also offers a promising avenue for managing the disease’s debilitating symptoms through innovative neurostimulation technology.
Allumiqs and Prolytix Form Strategic Partnership to Accelerate Drug Discovery and Development
Allumiqs and Prolytix unveiled an enduring strategic alliance on March 13, 2024, dedicated to providing synergistic and comprehensive solutions aimed at enhancing drug development pipelines for their clientele. This partnership aims to offer collaborative and integrated approaches, equipping customers with advanced bioanalytical solutions to propel drug candidates from initial research and development phases all the way to lot release. Through this joint endeavor, both entities aspire to redefine the landscape of pharmaceutical advancement, ensuring optimized outcomes and streamlined processes for their valued clients.
Following a series of fruitful collaborations with shared customers, this strategic partnership marks a significant milestone, harnessing Allumiqs’ proficiency in multiomics and LC-MS/MS solutions alongside Prolytix’s expertise in large-molecule drug product lifecycle management. Through this combined wealth of knowledge and resources, the partners present a unified front, delivering cohesive solutions designed to maximize efficiency and expedite progress within the drug development pipeline. This collaboration builds upon a foundation of proven success and underscores the commitment of both entities to driving innovation and facilitating breakthroughs in the pharmaceutical industry.
Allumiqs specializes in providing comprehensive biological insights and therapeutic characterization during the initial stages of a customer’s research and development endeavors. This includes delving into crucial aspects such as the mechanism of action, biomarker identification, and characterization of drug products. Armed with these invaluable insights, customers seamlessly transition to collaborating with Prolytix for tailored method development, specifically focusing on stability, potency, and GMP release testing.
This strategic collaboration ensures a smooth continuum in the R&D process, as customers benefit from a seamless integration of services and expertise offered by both companies. By working together, Allumiqs and Prolytix provide interconnected solutions and streamlined processes, supported by a blended team of experts. This collaborative approach significantly mitigates the complexities and risks associated with transferring critical R&D work between unfamiliar vendors, thereby enhancing efficiency and facilitating the advancement of groundbreaking pharmaceutical innovations.
“We found many synergies in working with the team at Prolytix in collaborative customer projects, most importantly our shared commitment to customer success. Now in partnership with Prolytix we can take all of our customers further in the drug development process with connected solutions from early R&D to lot release. Our goal is to make it simple for our customers to engage with the innovation partners they need at every stage of the drug discovery process, and our partnership with Prolytix does that.” Kent MacLean, CEO, Allumiqs Corporation.
“This is exciting news for our customers. Our partnership with Allumiqs is a natural one that further enhances our existing portfolio of products and analytical services to support the research, development, and commercialization of IVDs, clinical diagnostics, and large molecule biotherapeutics. We’ve already proven that linking our expertise and solutions together in customer engagements enables a robust scientific platform to optimize and advance biopharma research, and we look forward to building on this.” David Halverson, President and CEO, Prolytix.
The strategic partnership between Allumiqs and Prolytix promises to accelerate the drug discovery and development market by seamlessly integrating comprehensive biological insights with targeted method development, streamlining processes, reducing risks, and fostering innovation to propel pharmaceutical advancements forward at an accelerated pace.
SeaStar Medical Provides Updates on Enrollment of Adult Pivotal Clinical Study and Commercial Launch of Quelimmune, FDA-Approved in Pediatric Patients
SeaStar Medical Holding Corporation has revealed the granting of U.S. Patent No. 11,866,730, which features comprehensive provisions focusing on the utilization of their Selective Cytopheretic Device (SCD). This device is designed to treat individuals with inflammatory conditions and to manage activated leukocytes and platelets. The SCD stands out as an innovative extracorporeal therapy, specifically targeting exceptionally active inflammatory cells to dampen the inflammatory reaction. The company specializes in medical devices aimed at lessening the impacts of hyperinflammation on critical organs.
Eric Schlorff, CEO of SeaStar Medical, emphasized the significance of this patent in strengthening their intellectual property portfolio. He highlighted its alignment with their strategy to prove the effectiveness of their technology across various important clinical uses where hyperinflammation is a factor. Schlorff pointed out that uncontrolled hyperinflammation, regardless of its origin, can result in severe harm to vital organs, even death. SeaStar Medical’s SCD therapy is designed to specifically target the most active inflammatory cells, transitioning them into a healing state. This approach aims to halt the potential harm caused by these overactive cells and possibly even reverse the damage they inflict.
This recently granted patent involves techniques for utilizing SCD cartridges in the management of inflammatory ailments by externally isolating activated leukocytes and/or platelets, thus preventing or neutralizing their inflammatory effects. It also includes processes for handling these activated cells. Managing inflammatory conditions necessitates a careful balance of leukocyte and/or platelet numbers without excessively removing cells, which could impede the healing process. The patented methods specify that SCD cartridges must maintain particular ratios of surface area for isolating activated leukocytes and/or platelets to the inner volume of the SCD.
Contrary to methods such as pathogen removal and various blood purification techniques, SCD specifically aims at the most intensely active proinflammatory neutrophils and monocytes. The company has noticed that these hyperactive immune cells become dormant in a low-calcium setting. The SCD treatment imitates nature by establishing a distinct micro-environment that draws in these highly active cells and deactivates them in this specialized setting. Subsequently, these cells are reintroduced into the body via the bloodstream, prompting the body to prioritize its repair mechanisms.
Ventris Medical Receives 510(k) Additional Clearance for Amplify® Standalone Bone Graft Putty
Ventris Medical, a privately owned company specializing in orthobiologics and tissue regeneration, has announced today that the United States Food and Drug Administration (FDA) has approved 510(k) clearance for Synthetic Bone Graft Putty (Amplify®) in the intervertebral disc space. Amplify® introduces a novel category of synthetic biomaterials tailored to enhance cell growth and bone development. It consists of Amplify® biphasic (HA/βTCP) ceramic granules held within an alkylene oxide polymer carrier. This device is versatile, usable either independently or combined with autograft bone at a 1:1 ratio, serving as a bone graft extender.
Russell Cook, CEO of Ventris Medical, expressed satisfaction, stating, “We are delighted by the FDA’s approval of Amplify® Synthetic Bone Graft Putty for use in the intervertebral disc space. This innovation merges two extensively researched biphasic mineral elements, activated on the surface through our patented method, and suspended within our unique polymer carrier. In a market filled with numerous ordinary options, our focus as a company is on creating cutting-edge devices that inspire enthusiasm among surgeons and our distribution partners.”
John Brunelle, PhD, who serves as the Chief Operating Officer of Ventris Medical, stated that the Amplify technology platform aims to fill important voids in existing treatment methods, all the while enhancing the efficiency of surgeons. The surface-activated granules we’ve developed merge the proven clinical effectiveness of traditional biphasic materials with cutting-edge processing methods, resulting in a bone graft that aligns better with the body’s natural healing processes. This achievement marks the beginning of forthcoming product advancements and positions Ventris as a significant pioneer in the field of orthobiologics.
As per DelveInsight analysis, the global Orthobiologics market was valued at USD 5.33 billion in 2020 and is anticipated to grow steadily at a rate of 4.44% from 2024 to 2030, aiming to achieve USD 6.84 billion by 2030. The heightened demand for Orthobiologics primarily stems from the increasing challenges faced by the elderly population, who are more prone to various bone degenerative conditions, as well as the rising incidents of traumatic injuries such as those from road accidents and sports activities. Additionally, the market is set to benefit from increased investments in research and development, strategic collaborations among major manufacturers, and the steady rise in approvals for various orthobiologic products, among other factors.
