Managing metabolic disorders, including Type 1 and Type 2 diabetes, pre-diabetes, and insulin resistance, is increasingly challenging in today’s healthcare environment. These conditions are complex and costly, not only for those affected but also for the broader healthcare system. Traditional treatments often address symptoms rather than the underlying causes, leaving a significant gap in effective long-term management. As these metabolic issues become more prevalent, finding innovative and effective solutions becomes ever more critical.
Metabolic Syndrome Insulin Infusion Holdings LLC is at the forefront of addressing these challenges. This company is dedicated to revolutionizing how metabolic disorders are treated through the use of advanced FDA-approved infusion devices and biologics. Their approach includes personalized care plans and cutting-edge treatments like Physiologic Insulin Resensitization (PIR), designed to repair and enhance metabolic function. By focusing on individualized treatment strategies and leveraging innovative technologies, they aim to provide substantial improvements in patient health and overall well-being.
Guiding these efforts are experienced executives who bring a wealth of knowledge and leadership to the field. Their vision and expertise are instrumental in shaping the company’s approach to metabolic health, ensuring that treatment methods remain at the forefront of medical advancements. Their role underscores the commitment to enhancing patient outcomes and tackling the complexities of metabolic disorders with a forward-thinking perspective.
Innovative Solutions for Metabolic Disorders
MSII is dedicated to assisting individuals dealing with metabolic disorders, including Type 1, Type 2, pre-diabetes, and insulin resistance. Their treatments utilize FDA-approved infusion devices and FDA-approved infusion biologics. The physician-guided metabolic restoration program is tailored to each patient, offering personalized care plans designed to rejuvenate and repair the harm caused by metabolic failure. Recognizing the complexities of diagnosing metabolic failure and treating metabolic disorders, MSII offers an innovative approach.
Scaling Infusion Clinics for Improved Health and Cost Savings
The clinic model is derived from experience in the municipal payor market, the direct-to-payor market, and the clinical setting. Prior to joining Well Cell Global, all of Well Cell Global’s 180 infusion clinics were small-scale, successfully run, and physician-managed clinics within an existing practice. These clinics typically had 4-8 chairs and serviced the physicians’ practices with excellent patient outcomes.
It was realized that the Physiologic Insulin Resensitization (PIR) process produced significant healthcare cost savings for self-insured health plans and municipalities. Municipalities typically spend up to 70% of their total healthcare costs on metabolic dysfunction (Type 1 and Type 2) and its related cohorts. Partnering with municipalities allows for scaling the infusion clinics to 32 chairs, accommodating larger numbers of employees. This increased capacity improves health, reduces costs from medications, and enhances cellular function.
Additionally, partnerships with long-established surgical practices utilize the clinics to improve patient health and outcomes. These outcomes are targeted towards patients with metabolic dysfunction both pre-and post-surgery. These relationships also contribute to consistent patient flow and excellent clinic management.
Revolutionizing Diabetes Treatment with Hormonal Insulin Resensitization
An innovative and patented approach, Physiologic Insulin Resensitization™, is leveraged, where insulin is administered as a hormone rather than a conventional drug. This groundbreaking technique directly addresses the root cause of Diabetes—metabolic failure. By mimicking normal physiology, this modality aims to reduce insulin resistance, enabling blood sugar to enter cells more efficiently for energy conversion.
Enhancing Metabolism with Hormonal Insulin Communication
The use of insulin as a hormone communicator aligns with the body’s natural maintenance of optimized metabolism, distinguishing this approach from the traditional use of insulin as a symptom-suppressing drug. This physiologically identical method contributes to the reduction of insulin resistance, fostering a more natural and effective response.
Tailoring Metabolic Health Through Personalized Infusion Therapy
Every individual’s level of insulin resistance and carbohydrate metabolism efficiency is distinct. To commence the journey towards personalized care, a consultation is initiated to determine medical necessity and establish a customized plan directed by physicians.
The personalized care plan generally consists of an “Induction Phase” involving two infusions per week, gradually reducing to one per week over approximately 90 days. This is followed by a “Maintenance Phase,” where the focus is on achieving a harmonious balance between optimized metabolism and insulin sensitivity while striving to extend the intervals between treatments.
It is important to note that metabolic impairment is a chronic condition. While the treatments offer significant improvements, discontinuing therapy may result in diminishing benefits over time. The goal is to manage symptoms effectively, acknowledging that this is not a cure but a transformative approach to enhance overall metabolic health.
Enhancing Treatment Through Advanced Infusion Technology
Integrating technology into treatment protocols can significantly enhance effectiveness and safety in several ways. First, FDA approved infusion pumps track data and allow for personalized treatment plans based on an individual’s data. Approaching treatment with this precision increases the likelihood of successful outcomes by targeting unique patient needs.
Secondly, the pumps have remote monitoring characteristics. All treatment is administered in clinics with medical supervision, as all data is relayed and stored in the computer system for data collection. In addition, the data from each pump is sent to the company that owns the pump for advanced analytic techniques to update the algorithms controlling the pumps. The data is also used for additional research on the benefits of insulin infusion methods.
Research Highlights on the Efficacy of Physiologic Insulin Resensitization
Papers documenting patient outcomes from Physiologic Insulin Resensitization (PIR) treatment have been published. One research paper, published in the Journal of Diabetes and Its Complications, follows two patients with diabetic retinopathy through their PIR treatment.
Patient 1, a 69-year-old male diabetic for over 20 years, was diagnosed with severe proliferative diabetic retinopathy in 2017 and had an HbA1c of 9.2. He was visually impaired with reduced driving ability. In December 2017, he began PIR treatment. By January 2021, his retinopathy had improved to mild non-proliferative diabetic retinopathy, and his HbA1c had decreased to 6.3 by March 2021. He was driving during all daylight hours.
Patient 2, a 79-year-old female diabetic for seven years, had moderate nonproliferative diabetic retinopathy, an earlier stage of the condition. She began PIR treatment in October 2021, and by June 2022, her retinopathy had been downgraded to no apparent retinopathy.
Another research paper, published in the International Journal of Diabetes & Metabolic Disorders, analyzes two patients through case reports. Both patients experienced neuropathy and slow wound healing but showed improvements with PIR treatment. Patient 1 regained sensation, starting in the heel and moving towards the toes, stating, “I can feel the bottom of my feet again.” Patient 2 had diabetic wound ulcers heal within weeks rather than months.
A third research paper, published in the Journal of Endocrinology and Disorders by Jonathan Lakey, analyzed three diabetic and pre-diabetic individuals and their improved kidney function after starting PIR treatment. All three patients initially had low eGFR scores, classifying them as CKD (chronic kidney disease) stage 3 or higher.
Patient #8, presented with CKD Stage 3 and peripheral neuropathy, showed a decrease in all tested metrics after 15 weeks of PIR treatment, correlating to about 20 infusions. Metrics decreased as follows: 46% BUN, 34% creatinine, and 67% eGFR. Patient #8’s classification regressed from CKD Stage 3b to 3a.
Patient #30, pre-diabetic with an ulcerated wound, experienced improvements after 15 weeks of PIR treatment, about 20 infusions. Metrics improved as follows: 21% BUN, 24% creatinine, 38% eGFR, and A1C decreased by 2%. Patient #30’s CKD classification regressed from 3a to 2.
Patient #32, initially diabetic with diabetic neuropathy, received five weeks of PIR infusions, totaling 8-10 treatments. Improvements included a 46% decrease in BUN, an 18% decrease in creatinine, 27% increase in eGFR. Notably, potassium levels decreased from 5.9 mmol/L, above the normal range, to 4.3 mmol/L, within normal levels, a 27% reduction. Patient #32 also reported a full percentage point decrease in A1C.
Expanding Treatment Access Through Insurance and Community Partnerships
Ensuring accessibility of treatment options to individuals from diverse socioeconomic backgrounds is crucial. Efforts are made to establish relationships with all insurance providers. The Center for Medicare and Medicaid Services (CMS) has a history of accepting billing for this treatment, and private insurance providers also cover billing for Physiologic Insulin Resensitization (PIR). Additionally, assistance is provided to patients with the insurance process to maximize their benefits and reduce out-of-pocket costs.
For patients without insurance, fair and transparent pricing is set for each infusion, taking into account the financial constraints of individuals from different socioeconomic backgrounds.
Collaboration with non-profit organizations is also a focus to address healthcare disparities and improve access to care for marginalized communities. Partnerships with an Atlanta-based FQHC and a Philadelphia-based public-private economic development corporation, involve supporting health clinics in underserved areas and will improve health equality.
Maintaining Compliance and Safety with FDA Regulations
Ensuring compliance with FDA regulations is of the utmost importance to maintain the safety, efficacy, and quality of the treatment. The parent company provides credentialing training for the use of FDA-approved pumps.
Addressing Rising Healthcare Costs Through Targeted Diabetes Solutions
Diabetes stands out as a primary driver of the relentless surge in healthcare expenditures. The prevalence of diabetes has been on an upward trajectory, imposing substantial economic burdens on healthcare systems. The financial strain on municipalities is significant, with escalating costs impacting their budgets and tax bases. The costs associated with managing diabetes extend beyond direct medical expenses to include indirect costs such as loss of productivity and disability. As a result, the relentless rise in diabetes diagnoses has become a central factor fueling the overall escalation of healthcare costs, all of which fall upon municipal governments and, therefore, the taxpayers.
A market plan addresses this pressing issue by offering solutions geared towards cost savings. Physiologic Insulin Resensitization (PIR) helps employers and municipalities reduce their overall healthcare expenditure. The focus is not merely on delivering value but specifically on alleviating the burden of rising healthcare costs, thereby positioning the offerings as essential for financial sustainability.
Clinics are currently being established in Virginia, including Newport News, Stafford County, and Accomack County. Each of these clinics has secure agreements with municipalities to expand access to PIR for underserved communities and leverage public health networks. The clinics also collaborate with leading healthcare providers and employees to establish PIR as a standard of care.
Plans for the future include expanding to locations in Maryland, the rest of Virginia, and the Philadelphia metro area.
