Insulet Corporation: Pioneering the World’s First FDA-Approved Tubeless Insulin Pump to Transform Diabetes Care

Diabetes is a common chronic non-communicable disease.,It has become a serious global public health issue.Data released by the International Diabetes Federation (IDF) show that,In 2021, the global number of adult patients with diabetes reached 537 million (10.5%), which translates to approximately one in ten adults being affected.Compared with 2019, the number of people with diabetes increased by 74 million, a rise of 16%. According to IDF projections, this figure will reach 783 million by 2045. The 46% increase is more than double the estimated population growth (20%) over the same period, and the prevalence among adults may reach one in eight.

Diabetes has become a prominent global public health issue. Worldwide, it is a major contributor to mortality, disease burden, and healthcare-related economic costs. Diabetes can lead to various complications, such as stroke, blindness, heart attack, kidney failure, and lower-limb amputation.

As a chronic disease, diabetes and its complications subject patients to prolonged physical and psychological suffering, while the extended treatment duration imposes a heavy economic burden on low-income families. These factors can lead to severe psychological disorders in patients, resulting in treatment discontinuation, which ultimately exacerbates the condition and creates a vicious cycle.

Founded in2000AnnualInsulet Corporation(hereinafter referred to as:Insulet) Headquartered in Massachusetts, it is a medical device supplier, with“Improving the Lives of Patients with Diabetes”as its mission, leveragingPioneering tubeless pump technology breaks down the barriers of traditional insulin pump therapy, providing superior treatment options and lifelong health benefits to patients with diabetes worldwide.

Approximately29Before the Chinese New Year,BrooksThree-Year-Old SonRobertDiagnosed with1Type diabetes.RobertThere was no family history of diabetes, so Brooks did not understand why his son had developed the disease and knew nothing about diabetes. After this,BrooksTreating the understanding of diabetes as a significant life mission, he diligently pursued self-education on the subject, reading as much literature as possible. As time went by,BrooksUnderstanding of diabetes is also increasing.

As a venture capital firm Prism Venture Partners Co-founder ofBrooksWe have also been researching and investing in diabetes companies, as well as founding new ones. At that time, insulin pump products were already available on the market, but they were expensive. As a next-generation approach to helping patients with diabetes,BrooksRecognized significant market opportunities.

On one occasion, while flying back from the West Coast, he engaged in a discussion with a friend about optimizing insulin pumps. His friend was a medical device expert,BrooksAfter describing the challenges their son faced with insulin injections and medication administration, the two discussed the concept of a single-use insulin delivery system and even sketched the appearance of the future product on the back of a napkin. Later, this“Napkin Concept”has also becomeInsuletThe Company's Main ProductsOmniPodprototype.

This conversation facilitatedInsuletthe establishment of, also the world's firstFDAApproved Tubing-Free Disposable Insulin PumpOmnipodLaid the groundwork.2000Year7Month,BrooksandMasonCo-foundedInsuletCompany,Duane DeSistoAppointed as the company's firstCEO, developed the company's first productOmniPod。OmnipodDue to its revolutionary tubeless, patch-on wearable design, safe and stable performance, and highly convenient user experience, it has rapidly gained global recognition among patients with diabetes (T1D，T2D) recognition.To date, there are approximately1200Used by tens of thousands of diabetic patientsOmnipodInsulin Pump.

InDeSistounder the leadership of,InsuletSuccessfully listed on the Nasdaq, with the stock ticker symbolPODD, with a market capitalization exceeding20hundred million U.S. dollars.

2014Year9Month,Patrick SullivanSuccessionDeSistoServes as the company's President andCEO。SullivanPreviously served successively asCytyc、HologicandConstitution Medical InvestorsThe Company'sCEO，During his tenure, the company’s operating revenue grew from $324.2 million in 2015 to $463.8 million in 2017.

2019Year1Month, the Company's Former Chief Operating OfficerShacey PetrovicMs. Assumes Office as the Company’s LatestCEOAlso serves as the company's President.

As of now,InsuletCompany Employees1900person, at over per share on the Nasdaq290USD, with a total market capitalization exceeding200ten thousand U.S. dollars. According toInsuletFinancial Report,2020Annual Revenue9.04hundred million U.S. dollars, with a gross profit margin of64.39%。2016to2020Revenue has maintained steady growth for five consecutive years.

2016–2020 Revenue Data (Unit: Million USD) Source: Insulet Official Website

According to the company's third-quarter financial report,InsuletCompany2021Revenue Achieved in the Third Quarter2.756hundred million U.S. dollars, compared to2020Q3 of the year's2.34USD 100 million year-on-year increase17.8%. Among them,Core ProductsOmnipodglobal total revenue2.603$100 million, Year-on-Year Growth22.7%, accounting for as much as of the total revenue94.4%。According to the company's projections, in the fourth quarter of this yearOmnipodRevenue will remain stable20%the aforementioned growth.

Insulet is committed to making life easier for people with diabetes and other conditions through its Omnipod product platform.

In 2003, Insulet received the first 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the OmniPod system. In early 2005, the commercial version of the OmniPod system was approved by the FDA.

The Omnipod insulin pump primarily consists of two components: the Pod (injection pump) and the PDM (controller).

First-Generation Omnipod Insulin Pump

The disposable injection pod contains a motor, chip, medication reservoir, infusion set, and battery, resembling a miniaturized version of a conventional insulin pump. Users fill the pod with insulin and apply it directly to the body.Itis a type ofCatheter-free, waterproof, Bluetooth-enabled wearable delivery device, capable of holding200Unit'sU-100Insulin,Provides continuous insulin delivery for up to three days.

Internal Structure of the Infusion Pump (Pod)

Controller (PDM) isoneHandheld Diabetes Management Device,Built-in Abbott FreeStyle blood glucose meter, enabling direct control of the Pod for insulin delivery, basal rate adjustment, cannula insertion, and more.。

June 2018, Omnipod's second-generation upgraded productOmnipod DASHInsulin Management System AccessFDAApproved for commercial use, it is the first and only one that can provide3a tubeless device for uninterrupted insulin delivery, and the only one that has passedDTSecandISO 27001Certified insulin pumps for network and information security.

Omnipod DASHThe system isInsuletLays the foundation for the company's future innovation.Omnipod DASHSame size as the previous generation,The biggest update is that the Pod can communicate with the PMD via Bluetooth,PDMAdd ColorTouch screen,The built-in glucose meter was removed, and communication with the Contour Next One (Bayer) blood glucose meter is now established via Bluetooth to administer insulin based on blood glucose readings. This feature update lays the foundation for connectivity with blood glucose meters, continuous glucose monitors (CGMs), and diabetes management apps.

Omnipod DASH: Bluetooth-Controlled Pod for Insulin Delivery

InsuletLeveraging Digital Technology for ExpansionOmnipodecosystem.Omnipod DASHThe system for users, caregivers, andHCPsProvides a suite of optional mobile applications to help streamline diabetes management. ThroughOmnipod DISPLAYApp, patients can view insulin pump-related data in real time and seamlessly share it with their doctors.Omnipod VIEWAllows parents, schools, physicians, and other authorized personnel to view the user's insulin pump information.The iOS Today View WidgetAllows users and physicians to simultaneously view information from the controller and the continuous glucose monitor on their mobile phones.

2020Year2Month19Day, Medical Device CompanyInsuletAnnounce Partnership withCGMAbbott andDexComEstablish a partnership, useDexCom G6and the next generationG7 CGMThe system’s sensor values predict glucose levels and automatically adjust the required insulin dose to help reduce the occurrence of hyperglycemic and hypoglycemic events. This collaboration has led toInsuletThe Company’s Latest-Generation Insulin Pump Product—Omnipod 5The Birth of.

According toInsulet CEO Shacey Petrovic stated that the system has currently obtainedFDABreakthrough Device Designation, and this year9All review materials were submitted in May, and the application is now in the final stage of pre-market review.

Compared to previous generations,Omnipod 5CancelledPDM, is currently the world's only tubeless automated insulin delivery system.Omnipod Integrating the patch insulin pump withDexComofDexcom G6Integrated continuous glucose monitors utilize built-in intelligent algorithms to predict changes in blood glucose levels, automatically adjust the user’s insulin dosage, and enable direct control via a smartphone application.

This Year3Month,InsuletThe company announcedOmnipod 5Results of the First Pivotal Trial of an Automated Insulin Delivery System.InsuletTwo groups are shown1Data of Patients with Type Diabetes:128Name14 - 70years of age, adults and adolescents,112Name6 - 13.9-year-old children. Baseline was14standard treatment period, followed by3months of automated insulin infusion, during which participants were not restricted in their diet and physical activity.

The results showed that, after three months, the mean of participants in the adult and adolescent groupsHbA1cFrom baseline7.16%Decreased to6.78%, the average blood glucose level decreased from161mg / dLReduce to154 mg / dL; the mean of participants in the pediatric groupHbA1cFrom baseline7.67%Decreased to6.99%, with the average blood glucose level decreasing from183 mg / dLDecrease to160 mg / dL。

Assistant Professor, University of ColoradoGregory ForlenzaIn agreement with the Principal Investigator,Omnipod 5Simplifies diabetes management while improving users’ overall clinical outcomes.

As patients with diabetes increasingly favor wearable devices and digital health continues to evolve,InsuletThe company continued to achieve counter-trend growth during the pandemic. However, senior executives repeatedly noted on the annual earnings conference call that competition in the automated insulin delivery system market will continue to intensify. Despite these challenges, but InsuletStill optimistic about overseas market expansion,Over the past year, the company has successively expanded its presence into seven countries., Chief Executive OfficerShacey Petrovicstated,Insulet Plans to further expand into specific regions and enhance global manufacturing capabilities.

Currently,InsuletThe company is headquartered in Acton, Massachusetts, USA, with branches in Canada and the United Kingdom. Its primary operations are conducted in North America, Europe, and Israel. The agency’s coverage spans North America, Europe, Israel, Australia, and India. “Our recent focus is on expanding our global footprint across the Middle East and Europe. In the medium term, we plan to further expand into the Asia-Pacific region,” said the company.CEOPresidentPetrovicSpeak.

In recent years, the prevalence of diabetes in China has shown a gradual upward trend. Currently, the number of people with diabetes in China has grown to rank first globally. Data shows that the number of people with diabetes in China has now exceeded1.298billion, of which2Type 2 diabetes is one of the most common chronic diseases among middle-aged and elderly individuals. This number continues to grow rapidly as the aging rate keeps rising. Additional data shows that China has approximately83.4Tens of thousands die from various complications caused by diabetes.

Diabetes is one of the key areas in healthcare, and currently, the market size of diabetes-related medical expenses in China is approximately6000100 million yuan, accounting for of the Chinese government's healthcare budget8%. Therefore, the government in formulating"Healthy China2030"In the strategy, chronic diseases such as diabetes are specifically designated as a core component of national healthcare.

In recent years, competition in China’s diabetes sector has intensified. Internationally, brands such as Abbott, Medtronic, and Dana are vying for market share, while domestically, innovative enterprises continue to emerge alongside traditional sales vendors. Currently, China’s insulin pump market is characterized by a “tripartite” landscape, primarily comprising three categories: classic tethered insulin pumps, real-time continuous glucose monitoring (CGM)-integrated tethered insulin pumps, and tubeless patch insulin pumps.

Kailian Medical was established in2014In its inaugural year, it simultaneously operated in bothIntelligent Product, Cloud Data Exchangeaspects, and jointly developed with partnersDiabetes and Rare DiseasesAPPPlatform and cloud-based data interaction system, establishing a communication channel between doctors and patients to form a care network, ensuring that patients' treatment receives continuous attention from physicians.

Kailian Le Pump Insulin Pump  Image source: Kailian official website

Its independently developed LePump insulin pump, in addition to being equipped withOLEDIn addition to the color screen and capacitive touch key functions, Bluetooth communication function, and data management function, the biggest highlight is the integration with the Kailian Cloud Intelligent Chronic Disease Management Platform and the insulin infusion application management software, Yinuo Pump.APP，Real-time transmission of diagnostic and treatment equipment data to the cloud-based management backend, enabling data viewing, sharing, review, and traceability.Collaborate with patients and their families to build a care network, achieve a semi-closed loop for intelligent glucose management, and strive to realize real-time blood glucose monitoring in the future, thereby enabling precise glycemic control and digital diagnosis and treatment.

10Month19Recently, MicroTech Medical (Hangzhou) Co., Ltd. successfully listed on the Hong Kong Stock Exchange. MicroTech Medical was established in2011For over a decade, we have been deeply engaged in the research and development of devices and the provision of services in the field of diabetes monitoring and treatment equipment, possessing nearly100the company's in-house R&D team, forming a “EquilPatch Insulin Pump System”and“AiDEXContinuous Glucose Monitoring System”A comprehensive diabetes management product line centered around。

MicroTech Medical's Independently DevelopedEquilPatch-type smart insulin pump, a tubeless insulin pump, has currently obtainedCEandCFDAof approval and certification, globally20Available in multiple countries.

MicroTechEquilPatch Insulin Pump Image source: MicroTech Medical official website

MicroTechEquilPatch-type insulin pump with1U/The error is only when infusing insulin at the basal rate per hour.0.4%, superior to the industry standard of ±5%; during high-dose insulin infusion, the error is within the industry standard of ±5%Domestic.

EquilPatch insulin pumps are semi-disposable devices that can be reused by periodically replacing the reservoir, subcutaneous infusion set, and adhesive baseplate. They can be worn for over two weeks, significantly reducing costs for patients with chronic diabetes, and are lighter in weight, only23g, delivering a more free and flexible experience.

Whether it is Insulet abroad, or Kailian Medical and MicroTech Medical in China, all are pioneers of innovation in the diabetes sector, committed to breaking down the barriers of traditional insulin pump therapy. We are delighted to witness the continuous innovative development of treatment and monitoring technologies in the field of diabetes, bringing hope to diabetic patients in China and around the world.

Reference: Insulet Corporation, Manufacturer of the World’s First Tubeless Insulin Pump – Siyu Medical Device Observation