• Cianna Medical

  Led · Debt Financing · Jul 2015

  Cianna Medical develops and markets SAVI technologies for breast cancer treatment, including a brachytherapy applicator and the SAVI SCOUT surgical guidance system. SAVI SCOUT uses passive non-radioactive electromagnetic wave technology to provide real-time guidance and can be placed in tissue up to seven days before surgery. The company received FDA clearance for SAVI SCOUT in late 2014 and is currently launching the product. The SAVI brachytherapy applicator delivers individualized radiation therapy and can reduce treatment time to about five days. Cianna is using new financing to support commercialization and ramp up adoption of the SCOUT system. Cianna Medical manufactures the SAVI strut-based brachytherapy applicator, which delivers individualized partial breast radiation from inside the breast after lumpectomy. The SAVI system uses multiple catheters to direct dose customization that minimizes exposure to healthy tissue and reduces complications. The company reports that 20,000 women have been treated with the SAVI applicator to date. Cianna is focused on expanding commercialization of SAVI both in the U.S. and abroad while continuing product development. Management has stated the company will selectively invest in its new product pipeline as commercialization ramps. To support these efforts, Cianna recently secured external financing to strengthen its working capital position. Cianna Medical manufactures and markets the SAVI multicatheter breast brachytherapy applicator, a single-entry device that enables customized, patient-specific accelerated partial breast irradiation (APBI) delivered in a shortened five-day course. The company intends to use new funding to expand sales and marketing of SAVI in the U.S. and internationally and to develop new products synergistic to its radiation oncology and surgery focus. Management notes SAVI is increasingly adopted by clinicians and patients, and the company is experiencing double-digit growth following use at hundreds of leading breast cancer treatment facilities. Clinical studies from institutions such as MD Anderson and UC San Diego have supported broader eligibility and improved outcomes with SAVI, including less skin toxicity and improved cosmesis. The company is based in Aliso Viejo, California, and emphasizes making APBI available to more women who choose breast-conserving therapy. Cianna Medical is an Aliso Viejo-based company developing treatments for early-stage breast cancer. It is a spinout from BioLucent, Inc. On April 7, 2009 the firm announced completion of a Series B funding round worth more than $10M. The company said the new funding will be used to commercialize its technology. Investors named in the round include Emergent Medical Partners, Saints Capital, Mitsubishi International, Fog City Fund, and several private individuals. The raise brings Cianna Medical's total capital raised to $19M. Cianna Medical is an Aliso Viejo-based spinout of BioLucent developing breast brachytherapy technology. Its core product provides a shortened course of high-dose radiation therapy for treating early-stage breast cancer. The company said it will use new funding to further commercialize that technology. Cianna announced a $9M Series A funding round to support those commercialization efforts. Investors in the round include Fog City Fund, Windamere Venture Partners, and unnamed individual investors.

• Rapid Micro Biosystems

  Led · Debt Financing · Dec 2014

  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.

• Spiracur

  Led · Debt Financing · Nov 2014

  Spiracur develops mechanically powered negative pressure wound therapy devices, including the SNaP System and the ciSNaP Closed Incision System. Its SNaP System is a 2.2‑ounce, battery‑free NPWT device that allows patient mobility and operates silently; both devices have received FDA 510(k) clearance and CE Mark approval. The company was founded out of the Stanford Biodesign Innovation Program in 2007 and is privately held. Spiracur says its technology is designed to be portable and disposable to address limitations of traditional NPWT systems. With the announced financing, the company plans to launch new products into new care settings, expand globally, and grow sales, marketing and R&D investment. The $16 million financing from GE Capital supports those commercialization and expansion efforts. Spiracur is a Sunnyvale, California developer of an ultraportable, single-use negative pressure wound therapy (NPWT) device called the SNaP Wound Care System. The SNaP device eliminates the need for an electric or battery-powered pump, is silent, and weighs only 2.2 ounces so it can fit under a patient’s clothing. The SNaP System received FDA clearance in August 2009 and obtained CE Mark approval in December 2010. The company plans to use new capital to fund commercialization of the SNaP Wound Care System throughout the United States and the European Union and to support further R&D. Spiracur closed a $35M equity financing to support those efforts. Eric J. Kim of Maverick Capital joined the company’s board in conjunction with the financing. Spiracur is a medical-device developer that makes a device used to heal small wounds effectively. The company raised $20.3 million in a second round of funding reported by VentureWire. Investors in the round were Kleiner Perkins Caufield & Byers, New Leaf Venture Partners and De Novo Ventures. Spiracur has raised $24.3 million since its inception in 2007. The technology is based on work from a bio-design program at Stanford University. The company is based in Redwood City, Calif., and the articles note that not much is known publicly about its underlying technology.

• Cardiva Medical

  Led · Debt Financing · Aug 2014

  Cardiva Medical is a privately held medical device company focused on transforming vascular closure with its VASCADE and VASCADE MVP systems. VASCADE has been PMA-approved by the FDA since 2013 and demonstrated a statistically significant reduction in access-site complications in the randomized RESPECT trial. VASCADE MVP is the only marketed vessel closure technology designed specifically for electrophysiology procedures and received PMA approval in late 2018 after the AMBULATE trial. The company announced a $45 million equity financing to support continued commercial expansion of these systems and to fund other clinical and operational initiatives. Cardiva targets the more than 5.5 million catheter-based coronary, peripheral, and electrophysiology procedures in the U.S. that require access-site closure each year. The company is headquartered in Santa Clara, California, and has received industry recognition including the Shingo Bronze Medallion. Cardiva Medical is a privately held medical device company headquartered in Santa Clara, California, focused on developing and commercializing vascular closure technologies. Its flagship product, the FDA‑approved and CE‑marked VASCADE Vascular Closure System, is commercially available in the United States and demonstrated a statistically significant reduction in access site complications in the randomized RESPECT study. The company is advancing an investigational mid‑bore vein closure system through the IDE AMBULATE trial, which targets 6–12 French access sheaths used in cardiac ablation and other procedures. AMBULATE is a prospective, multi‑center, randomized, controlled study enrolling 204 patients across U.S. sites to compare Cardiva's system to standard manual compression and to shorten time to ambulation. Cardiva reported a high rate of VASCADE sales growth and recently closed on an additional $11 million, bringing total equity and debt financing in the current round to $41 million. Proceeds will fund U.S. commercial expansion of VASCADE and support the AMBULATE trial. Cardiva Medical develops and commercializes the VASCADE Vascular Closure System. The company plans to use new funding to continue commercial expansion of VASCADE and to develop proprietary closure technologies. Cardiva reported a $30m equity financing led by affiliates of Luther King Capital Management, PTV Healthcare Capital and the Canepa Advanced Healthcare Fund. The company is led by President and CEO John Russell. VASCADE demonstrated a statistically significant reduction in access site complications in the prospective, randomized RESPECT clinical trial. The RESPECT study included 420 patients at 20 U.S. centers comparing VASCADE to manual compression for femoral arterial closure. Cardiva Medical develops and commercializes vascular closure technology designed to help the body heal itself following catheterization procedures. Its product line includes VASCADE, a vascular closure system, and the Catalyst II and Catalyst III devices for aiding manual compression. VASCADE received FDA approval in 2013 and CE marking in 2012; Catalyst II and III were cleared by the FDA in 2007 and 2009, respectively. The company says it is ramping up commercialization of its vascular closure products. To support that commercialization, Cardiva has taken on a senior secured credit facility to provide working capital. Cardiva is privately held, was founded in 2002, and is based in Sunnyvale, California. Cardiva Medical develops a vascular closure system and is based in Sunnyvale, California. Its vascular closure system received FDA approval in February. According to an SEC filing dated July 29, the company has raised nearly all of the $3.5 million it was seeking, with only $2,367 remaining to close the deal. About this time last year the company completed the third tranche of a Series 2 financing. The filing lists officers and directors including President and CEO Charles Maroney, founder and former CEO Augustine Lien, and Co‑Founder and VP of R&D Zia Yassinzadeh, among others. The company could not be reached for comment and the article does not disclose revenue, users, or investor details.

• GeneSight

  Participated · Debt Financing · May 2014

  Assurex Health offers GeneSight, a treatment-decision-support test powered by CPGx™, its proprietary combinatorial pharmacogenomics technology, which measures multiple genomic variants and weights them together to provide genetically-driven medication information for each patient. The company recently enhanced the GeneSight Psychotropic test to give providers an expanded range of options for treating depression, anxiety, bipolar disorder, PTSD, schizophrenia and other behavioral health conditions. To date more than 14,000 healthcare providers have used GeneSight to help make treatment decisions for over 230,000 patients across the country. Led by President and CEO Virginia C. Drosos, Assurex will use additional funding to continue to increase adoption of GeneSight. The company also serves chronic pain conditions through its treatment decision support offerings. Assurex Health provides healthcare providers with GeneSight, a treatment decision‑support platform that analyzes how a patient’s genetics affect responses to medications for behavioral health and chronic pain. GeneSight evaluates a patient’s cheek swab against over 785,000 genetic–medication permutations and reports on 38 FDA‑approved medications across depression, PTSD, bipolar disorder, schizophrenia and other mental health conditions. Results are delivered in an actionable color‑coded report available 36 hours after Assurex receives a patient sample. The company also offers financial assistance programs for eligible patients. Led by President and CEO Virginia C. Drosos, Assurex is using proceeds from a $30M equity financing to support increased clinical adoption and further development of its GeneSight products. Assurex Health is a Mason, OH–based personalized medicine company that provides clinically-relevant individualized genetic information to help physicians select medications for depression, anxiety, chronic pain, ADHD and other neuropsychiatric disorders. Its core product is the GeneSight® suite, built on proprietary pharmacogenomics technology combined with evidence-based medicine and clinical pharmacology. The company has licensed patented technology from Mayo Clinic and Cincinnati Children’s Hospital Medical Center. Led by CEO James S. Burns, Assurex intends to use the proceeds from its financing to support increasing clinical adoption of its GeneSight products. The company secured a $32M financing comprising a $25M term and revolving credit facility and a $7M equity financing from existing investors.

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