SALE OF BioInspire Technologies, Inc.
Gerbsman Partners (www.gerbsmanpartners.com) has been retained by BioInspire Technologies, Inc. (www.bioinspiretechnologies.com) to solicit interest for the acquisition of all, or substantially all, the assets of BioInspire Technologies, Inc.
BioInspire Technologies (BioInspire) is a privately held biotechnology company located in Palo Alto, California, founded in 2009. BioInspire has developed a bioabsorbable, drug eluting implant for targeted drug delivery with initial focus in the ENT market. The acquisition of BioInspire enables immediate access to proprietary technology and preclinical combination products.
BioInspire has a patent portfolio that consists of eight (8) US patents covering broad claims covering product formulation, indications, manufacturing and methods of delivery. These cover multiple applications in the pipeline.
BioInspire has developed:
- A novel technology for targeted drug delivery via a protein based, bioabsorbable implant, SinuBand
- Techniques for manufacture and testing of the SinuBand implant
- Approved 510(k) for the SinuBand implant (w/o API)
- Eight (8) US patents with pending applications in EU
- Patented delivery method for ENT applications
BioInspire has no recurring revenues, product or collaboration related. Its value lies in the preclinical and clinical assets produced by its underlying and proprietary technology.
IMPORTANT LEGAL NOTICE:
The information in this memorandum does not constitute the whole or any part of an offer or a contract.
The information contained in this memorandum relating to BioInspire’s Assets has been supplied by BioInspire. It has not been independently investigated or verified by Gerbsman Partners or its agents.Potential purchasers should not rely on any information contained in this memorandum or provided by BioInspire, or Gerbsman Partners (or their respective staff, agents, and attorneys) in connection herewith, whether transmitted orally or in writing as a statement, opinion, or representation of fact. Interested parties should satisfy themselves through independent investigations as they or their legal and financial advisors see fit.
BioInspire, Gerbsman Partners, and their respective staff, agents, and attorneys, (i) disclaim any and all implied warranties concerning the truth, accuracy, and completeness of any information provided in connection herewith and (ii) do not accept liability for the information, including that contained in this memorandum, whether that liability arises by reasons of BioInspire’s or Gerbsman Partners’ negligence or otherwise.
Any sale of the BioInspire Assets will be made on an “as-is,” “where-is,” and “with all faults” basis, without any warranties, representations, or guarantees, either express or implied, of any kind, nature, or type whatsoever from, or on behalf of BioInspire or Gerbsman Partners. Without limiting the generality of the foregoing, BioInspire and Gerbsman Partners and their respective staff, agents, and attorneys, hereby expressly disclaim any and all implied warranties concerning the condition of the BioInspire Assets and any portions thereof, including, but not limited to, environmental conditions, compliance with any government regulations or requirements, the implied warranties of habitability, merchantability, or fitness for a particular purpose.
This memorandum contains confidential information and is not to be supplied to any person without Gerbsman Partners’ prior consent. This memorandum and the information contained herein are subject to the non-disclosure agreement attached hereto as Exhibit A.
Historical Company Information
BioInspire was founded to develop novel technologies to address targeted therapeutics via resorbable stint/implant technology. Initial development focused on the cardiovascular market. Later focus transitioned to ENT markets for clinical success.
SinuBand FP Sinus Implant is a two-sided, sterile, single-use, bioresorbable dressing (Figure 1) that is applied after ethmoidectomy performed as part of endoscopic sinus surgery (ESS). The implant matrix is made from Fibrinogen Concentrate (Human), Polyethylene Glycol 400, Calcium Chloride Dihydrate and Riboflavin. Each implant contains 300-1200 µg fluticasone propionate (FP), an intranasal corticosteroid. Implants are two-sided with a white side to be placed against the mucosa and a yellow side containing a colorant (riboflavin), so that it is visible while it is being positioned on the sinus mucosa. The implant is pre-loaded in a single-use, disposable delivery tool for ease of insertion and positioning in the post-surgical ethmoid sinus. SinuBand FP Sinus Implant has a preliminary classification by the Office of Combination Products (OCP) as a biologic (BLA) combination product with biologic (Fibrinogen Concentrate [Human]), drug (FP) and device (delivery tool) constituent parts.
SinuBand FP is an implant that is to be used as a sinus dressing following ESS. A delivery tool pre-loaded with the implant is part of the product configuration to ease insertion of the implant through the nasal passage and placement on the ethmoid sinus surface. The dimensions of each implant to be inserted into the sinus are 2 cm x 0.9 cm with thickness < 0.5 mm.
BioInspire Company Profile
BioInspire Technologies (BioInspire) developed SinuBand FP (Fluticasone Propionate), a sinus implant intended for use following ethmoid sinus surgery to maintain sinus patency and serve as an adhesion barrier. The product reduces surgical edema and inflammation following ESS. SinuBand FP is a combination product with biologic (Fibrinogen Concentrate [Human]), drug (FP) and device (delivery tool) constituent parts.
The biologic component, Fibrinogen Concentrate, provides the structural matrix for the implant, similar to the use of a synthetic polymer in traditional nasal/sinus packing materials. Fibrinogen was chosen as the optimal material for the SinuBand products for several reasons:
- It can be formulated to create a solid, non-adherent film when dry with sufficient mechanical strength to allow ease of delivery.
- It conforms to and creates a barrier on the surface of the tissue while maintaining patency of the sinus; it does not obstruct breathing or normal post-operative sinus drainage.
- It is fully biocompatible and bioresorbable within the early post-operative period.
Impact of Technology on the Market and Why BioInspire Assets are Attractive
SinuBand Nasal Dressing: Cleared 510(k):
BioInspire’s SinuBand Nasal/Sinus Dressing is a Class I device that was cleared on July 27, 2016 under premarket notification review (K160101) by the Center for Devices and Radiological Health (CDRH). SinuBand is indicated for use in patients undergoing nasal/sinus surgery as a space-occupying dressing to separate mucosal surfaces and prevent formation of adhesions (SinuBand 510 (k) Summary).
SinuBand addresses Unmet Clinical Need
Intranasal steroids (sprays) are first-line therapy but poor compliance limits usage and effectiveness. Also, nasal sprays are unable to reach sinuses for full therapeutic impact. The alternative, oral steroids, are effective but have severe side-effects. Intranasal steroids can be used for surgical management Surgical Management. However, the underlying inflammatory disease continues. Post-surgical polyps and adhesion result in interventions. Medical therapy limitations apply to post-op care. SinuBand fills this unmet need by providing directed therapeutic impact via effective drug delivery as a vehicle to manage mucosal inflammation. The highly conformable film adheres to any wound or mucosal surface. SinuBand elutes fluticasone propionate post application and fully resorbs.
BioInspire’s Assets
- Intellectual Property
- Preclinical and safety studies have been completed on the SinuBand FP product demonstrating safety and efficacy
- Clinical feasibility via a controlled, randomized, partially double blinded study
- Techniques for manufacture and testing of the SinuBand implant
Development Pipeline
Initial pipeline focus is on optimizing steroid delivery in post-surgical and then allergic rhinitis applications. Multiple FDA pre-sub interactions have improved clarity on the post-surgical regulatory path. There is significant potential for expanding indications to other ENT and non-ENT indication
The assets of BioInspire will be sold in whole or in part (collectively, the “BioInspire Assets”). The sale of these assets is being conducted with the cooperation of BioInspire. BioInspire and its consultants will be available to assist purchasers with due diligence and a prompt, efficient transition to new ownership.
The Bidding Process for Interested Buyers
Interested and qualified parties will be expected to sign a nondisclosure agreement (attached hereto as Exhibit A) to have access to key members of the management and intellectual capital teams and the due diligence “war room” documentation (the “Due Diligence Access”). Each interested party, as a consequence of the Due Diligence Access granted to it, shall be deemed to acknowledge and represent (i) that it is bound by the bidding procedures described herein; (ii) that it has an opportunity to inspect and examine the Igenica Assets and to review all pertinent documents and information with respect thereto; (iii) that it is not relying upon any written or oral statements, representations, or warranties of BioInspire Inc., Gerbsman Partners, or their respective staff, agents, or attorneys; and (iv) all such documents and reports have been provided solely for the convenience of the interested party, and neither BioInspire nor Gerbsman Partners (or their respective, staff, agents, or attorneys) makes any representations as to the accuracy or completeness of the same.
Following an initial round of due diligence, interested parties will be invited to participate with a sealed bid, for the acquisition of the BioInspire Assets. Sealed bids must be submitted so that the bid is actually received by Gerbsman Partners no later than Monday, April 22, 2019 at 3:00 p.m. Pacific Time (the “Bid Deadline”) at Igenica’s office, located at 863A Mitten Road Ste. 100B2, Burlingame, California 94010. Please also email steve@gerbsmanpartners.com with any bid.
Bids should identify those assets being tendered for in a specific and identifiable way.
Any person or other entity making a bid must be prepared to provide independent confirmation that they possess the financial resources to complete the purchase where applicable. All bids must be accompanied by a refundable deposit check in the amount of $100,000 (payable to BioInspire, Inc.). The winning bidder will be notified within 3 business days after the Bid Deadline. Non-successful bidders will have their deposit returned to them.
BioInspire reserves the right to, in its sole discretion, accept or reject any bid, or withdraw any or all assets from sale. Interested parties should understand that it is expected that the highest bid will be chosen as the winning bidder and bidders may not have the opportunity to improve their bids after submission.
BioInspire will require the successful bidder to close within 7 business days. Any or all of the assets of Igenica will be sold on an “as is, where is” basis, with no representation or warranties whatsoever.
All sales, transfer, and recording taxes, stamp taxes, or similar taxes, if any, relating to the sale of the BioInspire Assets shall be the sole responsibility of the successful bidder and shall be paid to BioInspire at the closing of each transaction.
For additional information, please see below and/or contact:
Steven R. Gerbsman
Kenneth Hardesty
Blog of Intellectual Capital 