Seventh Sense Biosystems Files for IPO: Pioneering Painless Blood Collection with Microneedle Technology

“Say goodbye to terrifying needles and blood collection tubes. With just a finger prick to obtain a single drop of blood, you can complete up to 240 medical tests performed in professional clinical laboratories, detecting nearly everything from cholesterol to cancer.” This was the product pitch once promoted by Theranos, the former blood-testing unicorn.

However, Theranos later fell from grace overnight due to issues such as technological failures and falsified blood test results. Although its product was built on lies, it is undeniable that Theranos’s slogan—“Say goodbye to scary needles and blood collection tubes”—did resonate with investors and consumers to some extent.

Blood draw is rarely a pleasant experience for most children, and even for many adults. However, in modern medicine, blood sampling and testing enable the diagnosis of hundreds of diseases, making blood tests a common component of clinical diagnosis and health check-ups.

However, some individuals are not suitable for conventional needle-based blood collection due to issues such as needle phobia, hemophobia, excessively fine veins, or hemophilia, necessitating further optimization of existing blood collection techniques and procedures.

Founded in 2008, Seventh Sense Biosystems (“Seventh Sense”) has launched TAP, a portable, painless blood collection device designed to streamline the phlebotomy process and minimize discomfort. TAP not only enhances the blood collection experience but also, thanks to its ease of use, is suitable for various settings including homes and hospitals.

According to available information, the technology behind Seventh Sense originated from laboratory research projects conducted by Massachusetts Institute of Technology professor Robert Langer and Harvard University professor R. Rox Anderson. In 2008, Seventh Sense was officially launched by Flagship Labs, the startup incubator under Flagship Pioneering.

Currently, John McDonough serves as the CEO of Seventh Sense. Prior to joining Seventh Sense, he held CEO or senior executive positions at multiple startups and publicly listed companies, successfully leading two initial public offerings (IPOs), which has established him as a recognized authority in corporate operations and management.

Rick Bente, the current President of Operations at Seventh Sense, has extensive experience in the research, development, and design of medical devices. Reportedly, in the field of wearable medical devices alone, Mr. Bente boasts 15 years of industry experience and holds more than 50 patents.

Since its official launch in 2008, Seventh Sense has continuously garnered favor from the capital markets, driven by its product’s philosophy of disrupting traditional blood collection methods.

According to Crunchbase data, Seventh Sense has completed 17 funding rounds since its inception, raising a total of approximately $80 million. Its investors include prominent institutions and companies such as Flagship Pioneering (FP) and Novartis.

(Note: The figure only displays Seventh Sense’s major financing events; other rounds, primarily debt financings, are numerous and thus omitted for brevity.)

Among the numerous investors in Seventh Sense, the prominent firm FP has frequently appeared. The fact that Seventh Sense has secured multiple rounds of investment from FP underscores its strength as a developer of painless blood collection devices.

In addition, Novartis, another investor in Seventh Sense, has not only provided financial support for the company’s development and product R&D but also serves as a corporate partner, offering substantial support for the market application of Seventh Sense’s products.

Guided by the product development philosophy of painlessness and convenience, Seventh Sense has launched a portable blood collection system called “TAP.” Visually, TAP is extremely compact, with a diameter of approximately 4 centimeters. It collects 100 microliters of blood per use. The device features an internal chamber for storing anticoagulants, and its button-style design allows users to simply adhere it to the upper arm and press lightly to perform blood collection.

TAP enables painless blood collection, with its core innovation lying in its microneedle design. Unlike conventional phlebotomy needles, TAP features an array of 30 microneedles. When the user presses the button, the microneedle array penetrates the skin to access capillaries for blood sampling. During the process, the device releases an anticoagulant to facilitate blood collection and storage. Once the blood collection chamber is full, an indicator light on the TAP automatically illuminates to signal completion.

After blood collection is complete, medical personnel can transfer the blood for testing via the blood collection port located at the bottom of the device. The entire process, from initiation to completion of blood collection, takes approximately 2–3 minutes. This approach not only eliminates the cumbersome steps associated with traditional needle-based phlebotomy but also enables painless blood collection in a safer and more standardized manner.

Following multiple clinical trials, TAP received FDA 510(k) clearance in March 2017. The product is approved for use in healthcare professional institutions and settings such as hospitals, clinics, retail pharmacies, and laboratories. It can be utilized by healthcare professionals for health screening, athlete monitoring, clinical testing, and other medical diagnostic purposes. For example, in diabetes monitoring, healthcare workers can use capillary blood collected by TAP to test for glycated hemoglobin (HbA1c), an indicator commonly used to monitor blood glucose levels in patients with diabetes.

Following product approval, Seventh Sense has continued to advance clinical trials with the aim of expanding the indications for TAP, enabling the product to transition from hospital settings to home use, which aligns with Seventh Sense’s commercialization strategy.

Initially, Seventh Sense had planned to market its products to hospitals and clinics. However, after conducting research and evaluation, the company ultimately decided to sell directly to consumers. Stuart Blitz, former Chief Business Officer of Seventh Sense, previously stated publicly, “We are shifting from a centralized model of healthcare delivery to a decentralized one, which represents our future direction.”

In December 2019, Seventh Sense officially announced that the FDA had approved the expansion of TPA’s intended users to include non-medical personnel. This signifies that Seventh Sense has met the regulatory requirements for full entry into the home-use medical device market, thereby further expanding its product market potential.

To increase the blood collection volume of the device, Seventh Sense embarked on improving the original TAP and, after multiple design iterations, launched the second-generation TAP.

Overall, the second-generation TAP incorporates a standardized, detachable blood collection container designed to align with clinical laboratory workflows, allowing users to adjust the blood draw volume within the container’s specified limits. With the increased blood collection capacity, the second-generation TAP is clearly compatible with the testing requirements of a broader range of healthcare institutions. Additionally, while the product’s exterior design has been appropriately refined, it continues to utilize the original microneedle-based technology to achieve painless blood sampling.

Second-Generation TAP

In February this year, Seventh Sense announced that its second-generation TAP had successfully obtained CE certification and was approved for direct use in home settings.

Since its inception, Seventh Sense’s product development philosophy has centered on blood collection, with the company dedicating limited resources to blood diagnostics. Although this approach has somewhat constrained the direction of product development, it has also reduced risks associated with both product and corporate operations. Moving forward, Seventh Sense will actively pursue FDA clearance for its second-generation TAP device while expanding product availability to more regions, gradually penetrating the international market.