Spartan Medical Broadens Single-Use Sterile Instrument Portfolio to Improve Outcomes, Increase Efficiency, and Generate Cost Savings

September 16, 2024

Spartal Medical — Spartan Medical Sterile Minor Surgical Kit

Spartan Medical, Inc., a veteran-owned medical solutions company, has expanded the industry’s most extensive range of single-use, sterile, pre-packaged (SSP) surgical instruments for use in the Veterans Administration (VA), the Department of Defense (DoD), and select civilian hospitals and Ambulatory Surgery Centers (ASCs) nationwide. Spartan Medical products portfolio of single-use, sterile med tech includes micro and minor surgical convenience kits, kerrison rongeurs, spinal and general surgical retractors, dural repair kits, synthetic biologics, and a wide range of orthopedic pre-sterilized implants and devices.

In addition to their well-documented ability to reduce Surgical Site Infections (SSI), this set of innovative SSP solutions can substantially reduce the number of reusable trays and instruments per surgery, driving increased Operating Room (OR) throughput, lowering overall costs to re-sterilize while reducing environmental impact.

As Spartan Medical’s President Vince Proffitt explained, “when you have the opportunity to not only make the surgery safer for the patient but also improve the efficiency of a hospital’s whole surgical system, converting to single-use sterile instruments is a clear winner. Driving surgical innovation doesn’t always take the form of a flashy new implant — the most complex part of any surgery is the massive support system required to put the right tools in the right hands, well before they are needed.” Using its ‘target-backwards’ problem-solving methodology, Spartan’s SSP portfolio aims to streamline the sterilization, inventory, and set-up costs of preparing an OR for surgery. Mr. Proffitt continued, “improving this broader system is not only the greatest opportunity to improve surgical outcomes but also one of the best avenues to reduce the cost of surgical care.”

Single-Use Sterile Instruments Reduce OR Time and Saves Costs

As a key part of its SSP portfolio development, Spartan worked directly with VA and DoD surgeons across the spectrum, from routine procedures to battlefield trauma. The endgame was to build pre-sterilized convenience kits containing the optimal mix of instruments needed for both microsurgical and minorsurgical procedures for the OR, clinic, as well as forward operating locations. Spartan developed customized convenience kits from scratch, based on direct surgeon feedback, in less than 120-days from concept to commercialization. Proffitt added, “We are a solutions-oriented company, and once we understand the surgeon preference, we will source the necessary items to meet the clinical need … and if we can’t find it, we’ll make it.”

Spartan’s SSP portfolio helps to reduce sterile processing delays, limits the impact of staff shortages in sterile processing departments, minimizes redundant capital purchases, and ensures required instruments are sterile and ready for use, on time, every time. Single-use instruments can save up to 30 minutes of total OR time,i reduce OR set-up time by 30%,ii and avoid frequent delays in surgery due to reusable instrument unavailability.iii

Single-use sterile instruments’ efficiency improvements can dramatically increase OR utilizationiv and patient throughput, facilitating an extra procedure in up to 51% of days.v They also result in direct cost savings — depending on the surgery type, the avoided staff time and sterilization requirements can save hundredsvi to well over a thousand dollarsvii per procedure.

Single-Use Instruments Actually Reduce Environmental Impact

It is commonly — mistakenly — understood that sterile, pre-packaged instruments generate a greater environmental impact. In fact, when considering the full sterilization lifecycle and disposable plastic wrapping used to maintain sterility of each reusable metal tray, a published study found, “the environmental impact of [single-use sterile instruments] was significantly lower” than reusable instruments.viii

Spartan Medical is excited to offer this innovative portfolio of single-use, sterile, pre-packaged surgical instruments as part of its mission to provide the world’s finest medical products to our nation—particularly to our soldiers, veterans, and their families. All products and solutions referenced are currently available on contract at VA and DoD medical centers across the country and overseas.

Sheba Medical Center to Utilize Sequentify’s InfiniSeq Panel in Study to Detect Clonal Hematopoiesis in Cancer Patients

September 16, 2024

The Hematology Laboratory, Molecular Hematology Unit, at Sheba Medical Center, Israel’s largest medical center, is conducting a joint study utilizing Sequentify’s InfiniSeq™ Myeloid Malignancies Panel. This study involves leading clinicians from the Cancer Center Institute, Maccabi Healthcare Services, and Sheba Cancer Research Center, focusing on identifying Clonal Hematopoiesis of Indeterminate Potential (CHIP) in patients previously diagnosed with solid tumors. The results from this study aim to advance personalized medicine in oncology, potentially influencing future patient care protocols.

Sequentify’s myeloid malignancy panel is a highly effective tool for sequencing patients with myelodysplastic syndromes (MDS), myeloproliferative neoplasms (MPN), acute myeloid leukemia (AML), and chronic myeloid leukemia (CML). The straightforward and efficient InfiniSeq library prep protocol is an ideal choice for laboratories aiming to enhance or expand their sequencing capabilities, whether they are upgrading existing workflows or establishing new ones.

Dr. Dan Dominissini, Director of the Diagnostic Division at Sheba Medical Center, commented: “We are thrilled to partner with Sequentify on this study. As one of Israel’s leading research institutes and hospitals, ranked #9 among the world’s best hospitals by Newsweek, Sheba Medical Center is committed to staying at the forefront of diagnostic innovation. Our ultimate goal is to deliver better, faster, and more cost-effective results to our patients.” As part of the study, all patients will undergo sequencing using next-generation sequencing (NGS) technology, with all procedures conducted at the Sheba Medical Center facility to ensure the highest level of accuracy and depth in identifying CHIP.

Sequentify’s InfiniSeq technology reduces sample preparation time to just 3.15 hours, from DNA extraction to sequencing, using a single-tube reaction. It supports full automation and significantly reduces costs. The patent-pending InfiniSeq technology is compatible with most sequencing machines and seamlessly integrates into any lab workflow.

Optimizing Emergency Medical Services With Advanced Patient Data Management

September 16, 2024

How Better Data Management Improves Emergency Medical Services

In emergency medical services (EMS), each minute is valuable, and service response must occur fast enough to save lives. They make critical decisions involving patients’ lives with little time and information. Therefore, patient data management is the key to the success of their interventions.

Over the years, we have seen that EMS providers can implement new and more efficient solutions in patient data management systems using smart technology.

These systems can, in turn, optimize operations, enhance access to patients’ data in real time, and, most importantly, save people’s lives.

Challenges Facing EMS Today

Among the most critical problems, one may identify disbursed information systems, limited accessibility to up-to-date patient information, and communication delays between EMS groups and hospitals.

This can reduce the ability to provide optimal care at the right time, which, under the best of circumstances, is terrible for the patient and, at the worst, immediately catastrophic.

A good number of first responders arrive at the scene with no information concerning the patients, including their allergies, medication, or other conditions. Usually, the accompanying individuals or the patient himself provide that information.

This results in time wastage and even mistakes in the kind of treatment offered during emergencies, which can worsen the overall response.

Role of Advanced Patient Data Management Systems

Sophisticated patient management systems like electronic patient care reporting (EPCR) contain the above challenges, which is addressed by providing patient and team-related information to operational and emergency health care teams, such as the EMS teams, in a real-time environment.

Based on cloud technologies, artificial intelligence, and machine learning, these systems help first responders obtain the necessary information, including the patient’s history, possible allergies, medications, and vital signs.

Patient records can be coordinated in a single platform, allowing EMS teams to work closely with hospitals to achieve better coordination in emergency treatment.

Advantages of Adopting Complex Data Delivery Technologies in EMS

Real-Time Access to Patient Data

EMS teams can easily access a patient’s previous history, current medication, and other pertinent information, making treatment en route to the hospitals much more informed. This reduces the possibility of providing wrong interventions that can worsen the patient’s condition.

Seamless Communication and Coordination

Since patients’ data can be transmitted immediately to the emergency departments in the respective hospitals, such departments can be notified of the patients’ arrival accompanied by thorough information on their health status. This reduces the time it takes from the patients’ arrival to the time treatment begins.

AI-Driven Predictive Analytics

Sophisticated expert systems integrated with artificial intelligence can determine from available data what a patient is likely to require in terms of care, for instance, a probable case of cardiac event or respiratory complications. This helps the EMS teams modify the treatment plans that are ailing the respective patient to promote better results.

Reduction in Administrative Tasks

Data entry and patient documentation can be easily automated, thus helping the EMS personnel attend to more patients than paperwork. This leads to time savings, hence improving efficiency, and makes available resources to be channeled to other activities that require priority.

Overcoming Barriers to Adoption

Cost

Some of the smaller EMS providers, especially in rural regions, might not be able to adopt these superior systems because of their costs.

Hence, government grants and subsidies could facilitate these technological changes since the EMS teams may need funding to accommodate such a change.

Privacy and Security

Preservation of the patient’s sensitive data is essential, especially with the up-surging incidences of hacking.

EMS personnel need to be aware that their protocols must meet the guidelines of rules like HIPAA, for instance, and integrate good levels of encryption and cyber security into their organizations’ systems.

Advancing EMS With Technology for Better Care

Integrated patient management systems are now on the front line of transforming the delivery of emergency medical care. They provide EMS teams with appropriate tools to help in quick and accurate treatment, and they are starting to overcome longstanding issues in emergency response from the ability to provide real-time access to the information, the communication, and the use of predictive analytics.

Therefore, further funding and acceptance of these technologies will be critical to creating the best emergency healthcare systems as the future unfolds.

New Data Presented at ESMO 2024 Show that Veracyte’s Decipher Prostate Test Predicts Chemotherapy Benefit in Patients with Metastatic Prostate Cancer

September 15, 2024

Decipher Prostate Test: Veracyte, Inc. (Nasdaq: VCYT), a leading cancer diagnostics company, today announced that new data from a phase 3 trial of the multi-center, randomized STAMPEDE clinical trial show that its Decipher Prostate Genomic Classifier is prognostic for clinical outcomes and predicts benefit from docetaxel in patients with metastatic prostate cancer. The findings were presented today (Presentation #15960) at the European Society for Medical Oncology (ESMO) 2024 Congress in Barcelona. These findings support Veracyte’s plan to expand use of the Decipher Prostate test – currently widely used to guide care for localized prostate cancer – to patients with metastatic disease.

Prostate cancer accounts for a fifth (approximately 375,000) of all male cancer-related deaths globally and the number is expected to double over the next two decades.1 In the United States, it is the second-leading cause of cancer deaths among men, with more than 35,000 men expected to die of the disease in 2025.2 Most prostate cancer deaths occur in patients who first presented with advanced or metastatic disease.

“For patients with metastatic prostate cancer, adding the chemotherapy docetaxel to standard-of-care androgen deprivation therapy (ADT) can increase survival. However, patient response varies and today physicians have limited tools for identifying who will likely benefit from the drug and who won’t,” said Gerhardt Attard, M.D., Ph.D., Professor and John Black Charitable Foundation Endowed Chair in Urological Cancer Research at University College London and STAMPEDE trial co-investigator. “Our findings are important because they show that the Decipher Prostate test can help clinicians better distinguish patients with metastatic prostate cancer who receive the greatest benefit from docetaxel from those who don’t and may therefore avoid unnecessary toxicity.”

In the new study, researchers analyzed data for 1,523 patients with advanced or metastatic prostate cancer who were followed in the STAMPEDE trial for a median of 14 years. They found that higher Decipher Prostate test scores were associated with an increased risk of death in both groups. Additionally, among the 832 patients with metastatic disease, only those with higher Decipher Prostate scores received a significant survival benefit from the addition of docetaxel to ADT. These patients had a 36% reduction in risk of death (HR 0.64, 95% CI, 0.48-0.86) with the addition of docetaxel as compared to those with lower Decipher scores who did not significantly benefit (HR 0.96, 0.71-1.30; interaction p=0.039).

Notably, docetaxel was beneficial in patients with higher Decipher Prostate scores regardless of whether they had high- or low-volume prostate cancer. This is important because current clinical practice favors use of docetaxel in patients with high- but not low-volume disease.

“The Decipher Prostate test’s ability to help guide treatment for patients with localized prostate cancer is already proven in dozens of peer-reviewed publications and is the only molecular test to achieve ‘Level 1B’ evidence status in the most recent NCCN® Guidelines* for prostate cancer,” said Elai Davicioni, Ph.D., Veracyte’s medical director for Urology. “These new phase 3 data from the STAMPEDE trial now further prove the performance and utility of our test in patients with metastatic prostate cancer. We believe our test can have a tremendous positive impact on care for these patients.”

Veracyte expects to begin offering the Decipher Prostate test to patients with metastatic prostate cancer in early 2025, after its anticipated reimbursement by Medicare. MolDX, a program that establishes Medicare coverage for advanced molecular diagnostic tests, recently issued a local coverage determination for molecular testing in patients with metastatic prostate cancer, providing what Veracyte believes is a pathway to coverage for its test.

“We are excited about the new Decipher Prostate data presented at ESMO and the opportunity to advance cancer care for even more patients,” said Marc Stapley, Veracyte’s chief executive officer. “These important advances clearly demonstrate the power of our Veracyte Diagnostics Platform, which delivers high-performing cancer tests and a powerful evidence-generation engine. Ultimately, this novel approach helps drive widespread test reimbursement and adoption, along with new insights to support our pipeline. This includes expanding the use of Decipher Prostate now to patients across the prostate cancer continuum, from those who are low risk and can benefit from active surveillance, to those who are metastatic and can benefit from chemotherapy.”

About Decipher Prostate

The Decipher Prostate Genomic Classifier is a 22-gene test, developed using RNA whole-transcriptome analysis and machine learning, that helps inform treatment decisions for patients with prostate cancer. The test is performed on biopsy or surgically resected samples and provides an accurate risk of developing metastasis with standard treatment. Armed with this information, physicians can better personalize their patients’ care and may recommend less-intensive options for those at lower risk or earlier, more-intensive treatment for those at higher risk of metastasis. The Decipher Prostate test has been validated in more than 80 published studies involving more than 100,000 patients. More information about the Decipher Prostate test can be found here.

Urban Poling Supports VeDA’s International Balance Awareness Week

September 13, 2024

Urban Poling is proud to continue its long-standing partnership with the Vestibular Disorders Association (VeDA), a collaboration that has lasted for over four years. Our Activator® Poles have been widely recognized and used by the balance community in many countries, offering additional support and confidence to individuals whose mobility and quality of life are severely restricted by balance disorders. VeDA’s work and resources have been crucial for those seeking guidance and support, and we are honored to help raise awareness for their important mission.

Starting on September 15th, the International Balance Awareness Week will begin, and we are excited to join forces with VeDA and encourage others to participate in this global event. Together, we can raise awareness of the challenges faced by individuals with balance disorders, and of the vital resources VeDA provides to help this growing community.

To learn how you can get involved in Balance Awareness Week, visit VeDA’s official page.

For those interested in trying Urban Poling’s Activator® Poles, which offer greater stability and mobility, visit VeDA’s partner page, where special discounts are available.

About Urban Poling Inc.
Urban Poling Inc. is a Canadian company and a global leader in the promotion of fitness and rehabilitation through pole walking. Known for its innovative Activator® Poles, Urban Poling focuses on improving mobility, stability, and overall quality of life for individuals with balance disorders, neurological conditions, and those in post-surgical rehabilitation. The company’s products and programs are recommended by leading healthcare professionals worldwide, and Urban Poling Inc is dedicated to empowering people of all ages to live active, healthy lifestyles.

About the Vestibular Disorders Association (VeDA)
The Vestibular Disorders Association (VeDA) is the leading international organization dedicated to supporting individuals with vestibular disorders. Since its founding in 1983, VeDA has provided patients, caregivers, and healthcare professionals with essential resources, education, and advocacy to improve the diagnosis and treatment of vestibular disorders. VeDA aims to reduce the diagnostic journey for individuals with dizziness, vertigo, and imbalance, and help improve their quality of life through support and guidance.

LifestyledAI, Dongguk University Startup Technology Institute & UMUST R&D Partner | To Advance Global AI Deep Tech and Healthcare Businesses

September 13, 2024

On August 28, 2024, Dongguk University Startup Technology Institute announced the signing of a joint MOU with LifestyledAI Co., Ltd. and UMUST R&D to advance global deep tech and healthcare initiatives through the application of LifestyledAI’s cutting-edge, proprietary AI technologies (patent-pending).

With this agreement, the parties plan to promote mutual cooperation with the goals of:

Collaborating on AI-based technology development and commercialization
Establishing strategies and providing technical support for exploring overseas markets
Joint research and development (international joint R&D, workshops, and seminars)
Exchanging research personnel
Creating an industry-academia cooperation ecosystem for mutual growth

LifestyledAI is an AI deep-tech startup that seeks to revolutionize customer lifestyles through its proprietary AI-based technologies, including AI Ultra-Real Fitting for highly realistic virtual fashion and beauty try-ons, and a precise, easy-to-use AI body measurement system. With a vision to become a global leader in the practical application of AI image technology, LifestyledAI is dedicated to enhancing user convenience in the fashion and beauty e-commerce industries through its innovative AI solutions. As a resident company in Dongguk University’s Startup Incubation Center, it receives extensive support in areas such as international market expansion, industry-academia collaboration, faculty consulting, technology transfer, and commercialization.

UMUST R&D Co., Ltd. is a renowned global healthcare startup focused on the development of global healthcare and AI technologies. Its core areas of expertise include the development of AI-based medical devices and healthcare solutions, leveraging cutting-edge technologies to drive innovation in the medical industry.

Jinwan Kim, CEO of LifestyledAI:

“This partnership will allow us to further refine our proprietary AI technologies and accelerate their global commercialization, helping to advance the AI deep-tech and healthcare industries on a global scale.”

Director Gwangho Yoo, Head of Dongguk University Startup Technology Institute, commented

“This agreement will facilitate a collaborative research and development framework in the AI and healthcare sectors by leveraging in-house technologies and matching human resources to strengthen industry-academia collaboration.”

Kangpa Lee, CEO of UMUST R&D, stated, “We are dedicated to advancing the AI image technologies developed by LifestyledAI and working together to implement these innovations in the development of cutting-edge AI medical devices, while also enhancing our global business capabilities.”

GN BODYDOCTOR | A Kegel Muscle Exerciser & Effective Solution for Pelvic Muscle Health Concerns

September 13, 2024

GN BODYDOCTOR: As individuals age or go through life-changing events such as childbirth, maintaining pelvic muscle strength can become a challenge. However, it is often overlooked that Kegel exercises can effectively address these issues.

Kegel exercises, developed in 1948 by Dr. Arnold Kegel, were originally introduced to treat urinary incontinence in women post-childbirth and as they age. Over time, these exercises have been found to be effective for a broader range of health issues, including prostate issues, fecal incontinence, reduced sexual function, constipation, hemorrhoids, sciatica, uterine prolapse, and hip muscle sagging. Moreover, Kegel exercises have gained recognition for their ability to enhance sexual pleasure, making them a valuable tool for improving overall sexual function.

Recommended as one of the top five exercises by Harvard Medical Schoolⁱ, Kegel exercises target deep pelvic muscles. However, these muscles are often difficult to locate and engage, and achieving significant results typically requires performing hundreds of repetitions daily over several months. Recognizing the difficulty of this commitment, GN BODYDOCTOR has developed an innovative solution: the Kegel Muscle Exerciser.

A Convenient and Effective Approach to Kegel Exercises

The GN BODYDOCTOR Kegel Muscle Exerciser is designed to simplify Kegel exercises while maximizing results. With just 30 minutes of use per day, this device automatically locates and stimulates the pelvic floor muscles, making it easier for users to strengthen these critical muscles without the need for traditional exercise methods.

The exerciser’s cushion-like design allows users to incorporate pelvic muscle training into their daily routine. Simply place the device on a chair or sofa and continue with normal activities such as reading, watching TV, or relaxing with a cup of tea. The device will automatically perform the otherwise challenging Kegel exercises, effortlessly helping users build pelvic muscle strength while they go about their day.

Expanding Global Recognition

Since its launch, the GN BODYDOCTOR Kegel Muscle Exerciser has gained widespread consumer trust and recognition in its home market of Korea, where it stands out for its effectiveness and ease of use. The product has also experienced significant success in Japan, a market renowned for its high standards for health and wellness products. There, the Kegel Muscle Exerciser is regarded as an innovative Femcare product.

The growing reputation of GN BODYDOCTOR has expanded its reach beyond Korea and Japan, with the product now being introduced to the United States, China, Vietnam, Turkey, and other international markets to meet increasing demand.

Advanced Technology Meets Safety and Comfort

The Kegel Muscle Exerciser is equipped with 99 adjustable intensity levels, allowing users to tailor the device to their specific needs and preferences. Whether seeking gentle muscle stimulation or a more intense workout, the device’s settings are customizable to suit individual comfort levels. It also features a built-in 30-minute timer and an automatic power-off function for added safety and convenience.

The exerciser combines low-frequency electrical pulses with GN BODYDOCTOR’s proprietary technology to target not only the pelvic floor muscles but also deep core muscles. Through a series of cycles—relaxation, contraction, tapping, massage, and release—the device helps alleviate symptoms associated with urinary and fecal incontinence, prostate issues, sexual dysfunction, constipation, hemorrhoids, and sciatica. It also provides back pain relief and is popular with younger users for its hip-lifting effects, achieving firmer buttocks.

Certified for Safety and Efficacy

The GN BODYDOCTOR Kegel Muscle Exerciser is more than just a wellness tool—it is a Class III medical device, certified by the Korean Ministry of Food and Drug Safety and is a Class II personal medical device cleared by the U.S. FDA. These certifications affirm the product’s efficacy and safety, offering users peace of mind that they are using a trusted and scientifically validated healthcare solution.

U.S. customers interested in learning more or purchasing the product can contact GN BODYDOCTOR’s U.S. partner Wiser Living.

ⁱ https://www.health.harvard.edu/staying-healthy/5-of-the-best-exercises-you-can-ever-do

Matia Mobility Secures HCPCS Code for Tek RMD: A Groundbreaking Solution Now Covered by Medicare, Commercial Insurance, and the VA

September 13, 2024

Matia Mobility, a leader in durable medical equipment, is proud to announce that the Centers for Medicare & Medicaid Services (CMS) has granted a HCPCS (Healthcare Common Procedure Coding System) code for the Tek RMD (Robotic Mobilization Device). This milestone makes standing mobility more accessible to individuals with walking disabilities confined to wheelchairs, providing new opportunities for independence and improving both physical and mental well-being.

The Tek RMD, now covered by Medicare, commercial insurance, and the U.S. Veterans Administration, is revolutionizing mobility by enabling users to stand and move at eye level, empowering them to participate fully in daily life. This includes tasks like cooking, reaching high shelves, and engaging in conversations and social interactions from a standing position, which promotes both confidence and social inclusion.

Benefits of Standing: More Than Just Mobility

The ability to stand has long been recognized for its numerous health benefits. Physically, standing helps improve circulation, reduce muscle atrophy, enhance bone density, and aid in digestive functions. These advantages are especially critical for individuals who spend extended periods in a seated position. Mentally, standing fosters a sense of empowerment and autonomy, reducing the emotional and psychological strain often associated with being wheelchair-bound. Standing upright allows users to see the world from a new perspective, positively impacting their self-esteem and social interactions.

Beyond the physical and mental health benefits, standing at eye level enables individuals to carry out activities of daily living (ADLs) more easily. Whether it’s preparing meals, doing household chores, going to work, or even pursuing hobbies and interests, the Tek RMD allows users to regain control over their lives in ways that were previously unimaginable. This is particularly impactful for veterans and others with service-related disabilities, who can now experience a new level of freedom and dignity.

Expanded Coverage and Accessibility

With the HCPCS code now approved, individuals across the country can access the Tek RMD with greater ease, and financial barriers are significantly reduced. The device’s inclusion in Medicare coverage is complemented by support from major commercial insurers, making this innovative solution even more accessible. The U.S. Veterans Administration’s coverage of the Tek RMD is another major step in honoring and supporting veterans, particularly those who have sustained mobility-limiting injuries during their service.

“We are incredibly excited about this development,” said Steven Boal, CEO of Matia Mobility. “Receiving the HCPCS code from CMS means more people will have access to the life-changing benefits of the Tek RMD. Whether through Medicare, private insurance, or VA benefits, our goal is to help as many individuals as possible reclaim their independence and improve their quality of life.”

Matia Mobility has made insurance prior authorization accessible via its website at https://www.matiamobility.com.

For more information about the Tek RMD and how to access coverage, visit https://www.matiamobility.com.

About Matia Mobility

Matia Mobility is committed to providing innovative mobility solutions that enhance independence, dignity, and quality of life for individuals with disabilities. With a focus on cutting-edge technology and personalized care, Matia Mobility helps people of all ages and abilities experience new possibilities in mobility and daily living. Matia Mobility, reimagining mobility for people with walking disabilities.

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September 13, 2024

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Nordic Biotech Company Pila Pharma Raises Capital for New International Obesity Study

September 12, 2024

Pila Pharma News: An intense battle is being fought for global market shares in the world of weight-reducing medicine, where major players such as Novo Nordisk and Eli Lilly are the frontrunners. Now, a smaller Nordic biotech company, Pila Pharma, which is stock listed in Sweden, is aspiring to enter the scene. The company has recently raised 10 million SEK in a directed share issue to study drug tolerance and the effects of the company’s molecule on obesity. The Phase-2a-study will be conducted over the next year and could be decisive for the company’s future.

Pila Pharma was founded in Malmö, Sweden in 2014 by Native Dane, Dorte X. Gram. With a background as a veterinarian, Dorte X. Gram has been researcher at Novo Nordisk, where she was part of the obesity research team. She was the scientist that identified and highlighted the molecule that would later become Semaglutide, which today is the pillar of Ozempic and Wegovy, Novo Nordisk’s injectable obesity drugs.

According to Pila Pharma, the capital raised will support the study with the objective to assess the molecule’s safety in increased dosages, as well as to expand on the number of study participants to determine, though empirical statistical calculations, whether the molecule has potential as part of a new tablet-based obesity treatment.

Gustav H. Gram, CEO of Pila Pharma

“When the company was founded 10 years ago, obesity was barely recognized as an disease. But it certainly is today. The industry has traditionally focused on Type-2 diabetes, which is also a major market, but in recent years a new market for weight-reducing drugs has emerged. The new molecules, primarily of the type GLP-1, are highly potent, enabling them for potentially quick and significant weight loss in individuals with certain types of obesity.”

A Growing Market

In 2024, the industry is becoming increasingly focused on the concept of ‘functional weight loss,’ where weight loss is gradual but with a higher preservation of muscle mass. This is evident where GLP-1 is combined with other types of molecules. A lot of attention is also given to the development of oral solutions – tablet-based treatments – such as Pila Pharma’s.

The company notes that they are at a stage, where the hypothesis behind their technology has matured to a degree where it can be concretized and tested. The company will now initiate a study aimed at developing a new type of drug with a different mechanism for the enormous market for weight loss drugs, which is estimated to exceed €100bn / £80bn annually in 2030.

– We’re still at an early stage when it comes to the concepts surrounding weight loss medication, but with demand being as huge as it is, there will be room for many types of products. With this new capital we aim to explore whether we can lower body weight and thereby play a role in the market and potentially position ourselves uniquely by being the only company working with this particular mechanism for the treatment of obesity and other metabolic diseases, says Gustav H. Gram, referring to a potential partnership or acquisition. He adds:

– Obesity research has been a long time underway, and we are only now seeing major capital investments, as the potential benefits are now clear for all to see. It’s a global tendency that is a result of a global problem, and of course we want to tap into that a with a different solution.

The Next Big Step

Pila Pharma is in phase 2 of development of their innovative medicine, which can potentially aid in weight loss for obese type-2 diabetics. The company hopes to see the results of the study in about a year from when the study commences, and if successful, they will most likely look to continue with a larger phase 2b study.

In earlier studies, the company demonstrated good safety and signs of efficacy in regulating type-2 diabetes as well as a significant reduction in a biomarker that indicates risk of heart failure. The molecule is thus suggested to also have a strong cardiovascular profile in addition to the effects regarding blood sugar regulation and potentially weight reduction.

– If our study shows an effect on obesity, we will be the first and only company to have successfully used this type of molecule – a TRPV1-antagonist – for the treatment of metabolic diseases. Until now, this drug class has mostly been recognized in association with pain management. If the results are positive, we will be in a unique position to develop what we in the industry call a “first-in-class”-product. Not only would this be a significant achievement in the medical history, it would also position us as one of the few global late-phase biotech companies that is listed, with potential to enter the vast market for obesity medication, says Gustav H. Gram.

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