The Venture Codex

Participated · Equity · Mar 2021

Rapid Micro Biosystems develops the Growth Direct® platform, a growth-based, fully automated system for microbial detection in pharmaceutical, biologics, vaccine, and cell & gene therapy manufacturing. The system is designed to improve data integrity, regulatory compliance, and the efficiency of global QC processes by detecting contamination more quickly than traditional methods. A majority of the global top-20 pharmaceutical companies use the Growth Direct® System, and the company reports accelerating adoption as manufacturers expand drug and vaccine production. Rapid Micro Biosystems positions its technology to reduce errors, decrease risk of contamination events and product recalls, and maximize manufacturing capacity. The company is headquartered in Lowell, Massachusetts, with global locations in Germany and the Netherlands. Recent fundraising supports continued global expansion and commercialization of its automated QC platform across biopharma and advanced therapy manufacturing. Rapid Micro Biosystems develops the Growth Direct™ platform, a fully automated, growth-based system that automates the majority of standard microbial QC tests and delivers results in roughly half the time of manual methods. The platform is used by a majority of the top 20 biopharma companies and supports biologics, sterile injectables, cell and gene therapies, and vaccine manufacturing. Growth Direct reduces human handling, enables remote monitoring and data reporting, and is positioned to help manufacturers meet stricter regulatory and capacity demands. The company has its global headquarters and U.S. manufacturing in Lowell, Massachusetts, and additional global locations in Germany and the Netherlands. Rapid Micro Biosystems completed a $120 million financing to support commercial expansion, global supply chain and manufacturing capability, and product development. Among planned developments is a rapid sterility test being advanced through a partnership with BARDA to shorten final product release timelines. Rapid Micro Biosystems is a Lowell, MA-based provider of automated, growth-based rapid microbial detection technology for the healthcare product manufacturing sector. Led by CEO Robert Spignesi, the company develops the Growth Direct™ system, a growth-based platform that automates traditional microbial testing to detect contamination and improve quality control. Its products target manufacturers of pharmaceuticals, biologics, biotechnology products, medical devices, and personal care products. The company secured $60M in equity financing to support its operations. Rapid Micro intends to use the funds to accelerate global commercial expansion, expand operational capability, and drive product innovation. Rapid Micro Biosystems develops the Growth Direct™ System, an automated, non-destructive rapid detection and enumeration technology for microbial quality control in pharmaceutical and related manufacturing. The system accelerates detection and enumeration for sterility testing, environmental monitoring, and bioburden testing while eliminating manual steps and analysis. Growth Direct uses the natural autofluorescence of microbes, requires no reagents, and is stated to be the first automated technology addressing all microbial quality control applications while fitting current regulatory practices. The technology is in use by some of the largest organizations in the world. The company plans to use new investment to expand global commercial and manufacturing operations, with a strategic focus on growing commercial and operational capabilities in Asia, specifically Singapore. Management cites the expansion as supporting broader adoption of the Growth Direct system in pharmaceutical and medical technology plants across the region. Rapid Micro Biosystems delivers the Growth Direct System, an automated, non-destructive rapid detection and enumeration technology for microbial quality control in pharmaceutical manufacturing and related industries. The system automates sterility testing, environmental monitoring, and bioburden testing, using microbes' natural autofluorescence and requiring no reagents; the detection technology was first developed and patented by Dr. Don Straus, Ph.D. Growth Direct is used by some of the largest companies in the industry and is designed to fit with current regulatory practices to accelerate adoption. In July 2015 the company closed $19 million in senior credit facilities — a $16 million term loan with Solar Capital and a $3 million revolving credit facility with Comerica Bank — to provide working capital. Management said the financing provides additional flexibility to invest in new opportunities and to accelerate global commercialization and expansion of the technology.

Participated · Equity · May 2019

Vesper Medical is a privately held medical device company developing minimally invasive peripheral vascular products focused on treating deep venous disease. Its core product is the Vesper Duo™ Venous Stent System, a purpose-built family of venous stents designed to address anatomical challenges in the iliac and femoral veins. The company plans to complete development of the Duo system, run a large pivotal clinical trial and submit a Pre‑Market Approval (PMA) application to the U.S. FDA, and pursue CE Mark certification. Vesper cites deep venous disease as an under-treated condition affecting some 25 million U.S. adults and positions its stent portfolio to address those clinical needs. Vesper is a spinout of Intact Vascular and is using recently raised capital to advance development and regulatory milestones. The company’s devices are not approved for sale or use in the United States. Vesper Medical is advancing a differentiated portfolio of venous stents, including the Vesper Duo Venous Stent System, designed for the anatomical challenges of iliac and femoral veins. The company plans to use newly raised capital to complete development and perform in vivo testing required to obtain approvals for clinical testing of the Vesper Duo stents. Vesper is a privately held spinout of Intact Vascular and develops minimally invasive peripheral vascular products for deep venous disease. The company highlights a large addressable need, citing more than 25 million U.S. adults affected by deep venous disease and limitations of traditional treatments. Its press release cautions that the device is not approved for sale or use in the United States.

Participated · Equity · May 2019

Intact Vascular is a medical-device developer that makes a system for arterial dissection repair. The company is commercializing that system and plans further product development. Runway Growth Capital provided Intact with a $30 million loan to support those efforts. The financing comes as venture debt from Runway’s business development company, which provides senior term loans of $10 million to $50 million. Proceeds will be used to fund commercialization and future development of the arterial dissection repair system. Intact Vascular is a privately held medical device company that develops minimally invasive peripheral vascular products. Its core product, the Tack Endovascular System, is designed to improve peripheral balloon angioplasty results and repair dissections while leaving >70% less metal than stents and is CE Mark Authorized. The system is pre-loaded with six self-expanding nitinol devices for above-the-knee interventions or four for below-the-knee interventions and can treat multiple dissections with a single catheter. Following FDA approval for dissection repair after balloon angioplasty above the knee, the company is ramping commercialization and expanding sales, marketing, and clinical support staffing. Intact announced a $25 million financing led by Vensana Capital, closing an initial tranche with the remainder scheduled for draw down in 2020 to support commercialization. The company is preparing to release data from its TOBA III and TOBA II BTK clinical studies later this year and is sponsoring three clinical trials (TOBA II, TOBA II BTK and TOBA III). Intact Vascular develops minimally invasive peripheral vascular devices, primarily the Tack Endovascular System for precision dissection repair after balloon angioplasty. The Tack is a first-of-its-kind implant designed to leave minimal metal in the artery, reduce mechanical stress on the arterial wall, maintain vessel integrity, enhance blood flow, and preserve future treatment options. Intact is sponsoring three clinical trials (TOBA II, TOBA III and TOBA II BTK) to evaluate the device in above-knee and below-knee indications; TOBA II completed enrollment in March 2017, TOBA III is nearing full enrollment, and TOBA II BTK is actively enrolling. The company projected completion of primary endpoint analysis for the pivotal TOBA II trial and described 2018 as a watershed year for its clinical program. To fund regulatory and trial activities, Intact closed a $20 million Series C in a two-tranche structure intended to carry the company through PMA of the Tack Endovascular System. The company is based in Wayne, Pa., and is preparing to advance toward regulatory approval and commercial launch following pivotal trial completion. Intact Vascular develops minimally invasive peripheral vascular products, centered on the Tack Endovascular System for repairing arterial dissections following percutaneous transluminal angioplasty (PTA). The Tack system enables highly targeted arterial repair while minimizing metal left behind and arterial inflammation compared with stenting. The company is sponsoring three large international clinical trials: TOBA II, TOBA II BTK, and TOBA III, which study the Tack system in above‑the‑knee (ATK) and below‑the‑knee (BTK) peripheral artery disease and combinations with PTA and drug‑coated balloons. TOBA II BTK is the first pivotal FDA‑approved trial for a vascular implant below the knee to treat critical limb ischemia (CLI). Intact plans to use the new funds to advance its ATK and BTK clinical development program and multiple product development initiatives to expand the Tack system’s utility. The company is led by President and CEO Bruce Shook and is based in Wayne, PA. Intact Vascular develops minimally invasive peripheral vascular products centered on the Tack Endovascular System. The Tack System is designed to optimize results of percutaneous balloon angioplasty and to minimize the metal left behind and arterial inflammation associated with stenting. Over three years the company refined the implant and delivery system, conducted three international clinical trials enrolling more than 170 patients, and obtained a CE‑Mark for its above‑knee system. Intact Vascular plans multiple clinical trials above and below the knee aimed at demonstrating the Tack System’s value and advancing FDA approval. The company was founded in 2012 and is based in Wayne, Pa. The firm cites peripheral artery disease’s global prevalence (more than 200 million people) as the clinical need for its technology.

Participated · Equity · Feb 2019

Staytuned Digital builds a software suite for e-commerce brands focused on the Shopify ecosystem, aiming to be the "Salesforce suite for e-commerce stores." The company acquires and develops e-commerce applications and has purchased seven apps to date. It works with more than 28,000 customers and reported being EBITDA positive in the fourth quarter. Staytuned pivoted from a video-focused product early in its history and subsequently brought on new investors and team members, including Lauralynn Drury joining the founding team. Future plans include acquiring additional apps from a long pipeline, hiring more engineers, and scaling the product suite and go-to-market efforts. The company emphasizes high-margin software growth as the rationale for building a large hub of merchant-facing tools. StayTuned Digital offers a platform that optimizes video for each destination, pushes content to multiple platforms, and measures performance to inform further optimization. The company is officially unveiling its product while targeting publishers, digital-native companies, e-commerce retailers, brands, and eventually small businesses. StayTuned was founded by CEO Serge Kassardjian (formerly global head of media app business development for Google Play) and Randy Jimenez (previously CTO at SinglePlatform). The founders built the product to address fragmentation and frequent format changes across platforms so publishers needn’t manage each one individually. StayTuned positions itself as providing ubiquity to where audiences are rather than forcing publishers to abandon major platforms. Financially, the company has raised $2.5 million in funding and is part of the current GCT Startup-in-Residence program.

Participated · Series B · May 2014

Tarsa Therapeutics is a Philadelphia-based developer of a formulation of calcitonin for the treatment of postmenopausal osteoporosis. It is developing Ostora, a novel oral formulation of calcitonin intended for women more than five years post‑menopause when alternative treatments are not suitable. Ostora could become the first approved oral calcitonin; the article notes calcitonin is a natural hormone with a long history of safety and efficacy as a treatment for osteoporosis. Tarsa secured a $10M senior credit facility to support its development and regulatory plans. Oxford Finance LLC and Square 1 Bank provided the financing. The company intends to use the proceeds to support a New Drug Application (NDA) filing with the U.S. FDA for Ostora, currently targeted for early 2015. The company is led by President and CEO David Brand and added Daniel Soland to its board. Tarsa Therapeutics is a Philadelphia, PA-based company developing an oral formulation of calcitonin for the treatment and prevention of postmenopausal osteoporosis. Its lead product, Ostora, is described as a novel oral calcitonin formulation. The company raised $7M in a second tranche of a Series B round. Tarsa intends to use the funds to prepare for filing a New Drug Application (NDA) with the U.S. Food and Drug Administration for Ostora. Leadership includes President and CEO David Brand, and the company recently appointed Nicholas A. LaBella, Jr., MS, RPh, as Vice President, Global Regulatory Affairs. Existing investors participating in the tranche include Foresite Capital, MVM Life Science Partners, Quaker Partners and Novo A/S. Tarsa Therapeutics is developing OSTORA, a novel oral formulation of calcitonin for the treatment and prevention of postmenopausal osteoporosis. The company holds an exclusive licensing agreement with Unigene Laboratories that provides exclusive development and worldwide commercialization rights for OSTORA, except in China. Led by President and CEO David Brand, Tarsa intends to use the financing proceeds to support an NDA filing, prepare a European Marketing Authorization Application (MAA), and carry out essential pre-commercialization activities. In conjunction with the financing, James Tananbaum, MD, founder and CEO of Foresite Capital, is joining Tarsa's Board of Directors. Tarsa is based in Philadelphia, PA. The company closed a $28M Series B equity financing to fund these activities. Tarsa Therapeutics recently closed a $24M Series A and licensed a Phase III oral calcitonin program from Unigene Laboratories. The licensed oral calcitonin has the potential to become the first FDA‑approved and commercially available oral formulation of calcitonin for osteoporosis. Tarsa will be solely responsible for the costs of the recently initiated global Phase III clinical program and has reimbursed Unigene for its Phase III expenditures to date. As part of the licensing agreement Unigene will own 25% of Tarsa on a fully diluted basis and is eligible for milestone payments and royalties on product sales. The company named David Brand as President, CEO and Director and has a board chaired by Dr. Bednarski that includes representatives from Unigene, Quaker BioVentures and Novo A/S. Tarsa will be based in Philadelphia, PA.