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Lymo Investments is a multi-family venture fund based in Silicon Valley, CA. The firm is an active investor in the medical device sector, and is interested in opportunities worldwide. Initial investments are typically about $50,000 with the potential for follow-on investments totaling $500,000, and may be structured as equity or as debt. Lymo Ventures does not invest in seed rounds. In the recent past Lymo Investments has allocated new investments at a rate of approximately one every two months. The firm offers support and expertise to portfolio companies but does not seek a board seat.

TRANSVERSE MEDICAL INC is an early stage medical device company focused on the development of innovative technologies addressing the market of aortic embolic protection for Transcatheter Aortic Valve Replacement (TAVR), cardiovascular percutaneous interventions and surgical procedures. TMI’s proprietary Point-Guard™ technology is uniquely designed with the capability to conform to the aortic arch anatomy, deflect and filter embolic material from entering the major cerebrovascular arteries, collateral and adjacent arteries, and upon completion of procedure, safely and effectively remove the system with captured embolic debris.

Stroke rate is substantial in many established and emerging cardiovascular procedures.  Of particular interest in the field are the new Transcatheter Aortic Valve Replacement (TAVR) and Transcatheter Aortic Valve Implantation (TAVI) procedures.  There clearly exists an unmet need for an embolic protection and capture device that can be utilized during the procedures to significantly reduce acute strokes and adverse ischemic events, particularly in heart valve implantation & repair.

The risk of cerebral events and the need for protection during Transcatheter Aortic Valve Replacement is well documented in the literature and discussed by highly recognized key opinion leaders at major medical conferences around the world.  Stroke and the incidence of silent embolic events during TAVR are associated with high patient morbidity and mortaility.  This awareness of stroke, reported early on in the range of 2% to 11% prior to standardized endpoint definitions, is a concerning complication during TAVR and may have been attributed to early generation devices.  However, stroke continues to be reported in TAVR with rates in the range of 0.6% to as high as 7%, remaining roughly double those associated with surgical aortic valve replacment (SAVR). While the clinical and technical challenges of TAVR will continue to be addressed through lower profile devices and operator experience, the risk of stroke remains a major concern.

The market opportunity and adoption for TAVR continues to grow worldwide with a CAGR estimated at 19.8% (2014 to 2018) and worldwide market sales projection of $2.9 Billion in 2018. (Source: David Roman, Managing Dir., Global  Investment Research, Goldman, Sachs & Co.). The TMI Leadership Team estimates the Cerebral Embolic Protection Device (CPD) market to be at a conversion rate to CPD during TAVR at 50% by 2018, with worldwide market sales for CPD estimated at approx. $280 to $480 Million with an ASP of $3-5K. The Point-Guard™ advantages are expected to allow it to be used in 50% or more of such cases, projecting gross worldwide revenues of around $146 million by 2018.  Complications are limiting market growth (i.e., stroke) - - Controlling stroke (i.e., Point-Guard) can expand the markets and accelerate the expansion of TAVR use to lower risk patients, capture a larger portion of high/intermediate risk patients, set the "standard of care" (e.g 100% carotid filter use in US), and set the standard for other procedures (EP, AF, LAA, etc.).  Preliminary data presented at TCT 2014 by Dr. Axel Linke of University of Leipzig Heart Center in Leipzig, Germany showed significant reduction in early cerebrovascular accidents (CVA). Median Total Lesion Volume reported a 65% Reduction; Median Lesion Number reported a 57% Reduction; Rate of CVA reported a 67% Reduction. 

TMI is currently developing the POINT-GUARD™ Cerebral Embolic Protection System with VARIFLEX™ Conforming Technology. Point-Guard™ is the first complete embolic protection system engineered with VariFlex™ conforming technology, uniquely designed to conform to the aortic arch and branch artery ostia addressing the concern and possibility of residual flow redirecting around current embolic protection devices. The integration of VariFlex technology allows for maximum wall apposition to cover the aortic arch branch arteries with variable flexibilty and positioning. All other CPDs in the market have only met one or two areas of concern for CPD (Freeman, et al – “With all the embolic protection devices, potential limitations exist.”).  The Point-Guard is the only aortic embolic protection device designed to address all key features and functions of embolic protection during TAVR: conformity, deflection, filtration, and capture of emboli upon removal. Point-Guard will be the first cerebral embolic protection system to completely meet operator and procedural needs through ease of use, a low profile, safety and efficacy, compatible, and rapid delivery.

The Point-Guard™ is a class II product in the USA and can be cleared using the 510(k) process, with clinical trial results.  The number of clinical trial patients required is to be determined, but anticipated to be fewer than 100, including EU CE Mark clinical trial patients.  The CE Mark will be pursued first and is expected to require 50 or fewer patients with 30 day post-procedure follow-up.

TMI has raised $500K in private funding to date, is seeking additional seed funding of $1 million and series A funding of $6 million. 

Seed Funding will allow for completion of concept development & design freeze, pre-clinical development, testing, in vitro & in vivo studies, and first in human experience. Full Series A Funding will support European clinical trials (FDA Compatible), clinical product manufacturing & readiness, CE Mark approval & European pre-commercialization launch, strengthen IP and Filings, and general operation & administration.

Acumen Pharmaceuticals, Inc.

Direct to Brain Soluble Aβ Oligomer Selective Immunotherapy

First/Best in Class Therapy for Alzheimer’s Disease

Right Target - Right Patients - Right Delivery.  ACU-193 is Acumen’s monoclonal antibody drug candidate that targets soluble amyloid-beta oligomers (sAβo) with high affinity and selectivity.  Acumen is developing ACU-193 for direct intrathecal delivery to the brain via a device collaboration designed to increase the probability of early clinical success and enhance long term commercial potential.

The Only Alzheimer’s Immunotherapy Specifically Targeting Toxic sAβo Using Direct Brain Delivery.  ACU-193 is a late-preclinical, fully humanized monoclonal antibody that selectively targets sAβo, the primary pathologic agent in Alzheimer’s.  Composition of matter and use patents for ACU-193 run through 2030; and further IP protection is available.

Acumen is establishing an exclusive collaboration for access to FDA/CE approved chronic infusion pump systems for direct to brain drug delivery.  ACU-193 and direct brain delivery positions the program as a scientifically and clinically differentiated approach to Alzheimer’s with attractive long-term commercial and therapeutic potential.

Program Profile & Positioning

Scientific Background & Program History.  SAβo are widely recognized as the primary neurotoxins responsible for the acute cognitive deficits and progressive neurodegeneration in Alzheimer’s disease.  SAβo are non-fibrillic assemblies of Aβ peptides, and are distinct from protofibrils, fibrillar Aβ, and β-amyloid plaques.  Brain levels of sAβo are 3-8 orders of magnitude lower than levels of β-amyloid plaques or monomeric Aβ.  They are elevated in the Alzheimer’s brain, and studies suggest a correlation between levels of sAβo and cognitive deficits in Alzheimer’s.  SAβo bind with high affinity to mature synapses, most likely to a small number of highly selective neuronal receptors.  Binding to these receptors interferes with normal neuronal function leading to memory loss and neurodegeneration.  Because sAβo are present at concentrations that are 3-8 orders of magnitude lower than non-toxic monomeric and fibrillar Aβ, they are an optimal immunotherapeutic target.  However, because only approximately 0.1-0.2% of peripherally administered antibodies cross the blood-brain-barrier and reach the brain, brain exposure of peripherally administered antibodies may limit their therapeutic efficacy.  Acumen is pursuing intrathecal delivery of ACU-193 to ensure therapeutic levels of the drug candidate reach the brain and achieve effects.

Effects of sAβo.

Acumen pioneered research on sAβo.  The company’s anti-sAβo antibody program was licensed to Merck & Co. in 2003 for significant upfront and milestone payments.  ACU-193 is a third generation product of the ~8 year/~$70M partnership with Merck.  Merck advanced the program to a late preclinical development stage.  In November 2011, as part of Merck’s restructuring following its merger with Schering Plough, Acumen reacquired all rights to the program including ACU-193, backup molecules, and substantial IP with no financial or take-back rights obligations to Merck.

ACU-193 Details.  

• Humanized, affinity-matured, IgG2 monoclonal antibody with uniquely high selectivity for sAβo.

• Prevents binding of sAβo to neurons and sAβo toxic effects at synapses.

• Brain penetration, target engagement and robust biochemical and behavioral efficacy demonstrated in mouse models of Alzheimer’s.

• Excellent pharmacokinetics, bio-distribution and brain penetration demonstrated in 4 animal species.

• Excellent safety profile in exploratory studies in rhesus monkeys.

• GMP production cell lines and the necessary analytics established.

• Drug delivery collaboration with Medtronic for direct brain delivery.

• Companion diagnostic biomarker assay established.

• Composition of matter and use patent protection through 2030.

RCT Ventures invests in early-stage life science companies including medical devices, drug discovery platforms, and research tools.