However, less than 10% of all chest surgeries today are minimally invasive due to the large investment of time and money required by the surgeon and hospital to implement and become certified in these procedures. Additionally, there are little data to prove that a minimally invasive procedure has achieved more than a marginal improvement in patient recovery or care. 10 Invention Description The Physicist Assuage Retractor uses a new blade design and automation for smooth, steady retraction.
It has built-in sensors and phonemically informed algorithms which provide early warning and automatic avoidance of fractures and tears. The Assuage Retractor is also shaped very similarly to the retractors currently in use. That means that it is a “drop-in replacement” for current technology. There will be few if any changes in procedures for the user and training on the devise is very minimal. 11 Benefits 12 0 Less Pain, Faster Recovery, High Quality of Life (Patient): The new blade design reverts the retractor blades from crushing the nerves that run along the ribs.
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Automation, sensors, and algorithms work together to provide a smooth, steady pull on tissues and bone, which results in less tearing and no fractures. Because the patient is in 6 8 http://www. Grandiloquence’s. Com/SST-War/Tracheotomy. HTML 9 Physicist Executive Summary 10 Physicist Product Slideshows 11 12 7 Technology Screening – Confidential – For Duke CT’ Use Only – Do Not Distribute page 2 of 17 less pain, night-time respiratory rates in post-operative patients remain normal. This dads to normal blood oxygenation, less analgesia, and faster recovery times. Lower patient care costs (Hospital): Due to patients recovering more quickly after surgery, there will be shorter stays in the Intensive Care Unit (ICC) and less need for intensive post-operative care (including analgesia). 0 Few if any changes required to the Operating Room (OR): Physicist’s Assuage retractor is a drop-in replacement for the current retractors used in the hospital. As a result, there is no need to purchase new equipment or substantially change current OR set up or procedures.
That means no staff retraining costs. Applications The current retractor model developed by Physicist is for use by hospitals and surgeons for open-chest procedures. However, the technology used can be applied to other applications including, “orthopedic surgery, spinal surgery, and international cardiology’ or any surgery where tissue retraction is required. 13 RECOMMENDATION Strengths 0 No significant retractor advances in over 50 years: The thoracic retractors currently in use were developed in 1936.
With no major innovations in the area for the last 74 years there remains a significant opportunity for a technologically advanced device hat could facilitate the process and improve the results of open-chest surgeries. 0 Full access surgeries remain the “Gold Standard” of care: The opportunity in traditional surgery remains the larger market compared to less-invasive methods. Most chest surgeries are still open, full access surgery (either Tracheotomy and Storerooms); about 600,000 surgeries per year in the US. Costly on people older than 65, a group that will grow 50% by 2030 in the US and other developed nations. 14 Further growth will be driven by the obesity/diabetes epidemic in developed nations, plus growing demand for more intensive medical are in developing nations. These trends will drive growth. 0 A broad application base for the technology: The sponsor’s technology can be applied to other devices, including instruments used in orthopedic surgery, spinal surgery, and international cardiology, creating US markets for the sponsor’s products exceeding $1 B and world-wide markets exceeding $28. 5 13 15 14 page 3 of 17 0 Increased profitability for hospitals: Pressure from payers forces hospital administrators to cut costs while still improving patient care and satisfaction. Current billing practices greatly reward hospitals that decrease the cost of post-surgical care. Hospitals will make money if they use Physicist’s Thoracic retractor as a result of lower overall costs, shorter times in the ICC and wards, less intensive post-pop care, no need for staff retraining, increased patient satisfaction and customer “pull. 0 The Assuaged Smart Retractor is a 501(k) device: The retractor will be a 510(k) device, the Fad’s least stringent level of regulatory approval with no reimbursement code needed and claims of efficacy will be possible after completion of successful clinical trials in 2003. 0 A ‘Drop-Len’ replacement for current instruments: Surgeons have resisted adopting any minimally invasive procedures because of their high cost, increased complexity, and lengthy training. In contrast, Physicist’s retractor will be an easy-to-use, inexpensive, drop-in replacement for current retractors, requiring almost no training. A Robust Design: The device has a reusable retractor and disposable parts for each surgery. There are different consumables for tracheotomy and for storerooms, with each possessing proprietary technology unique to each procedure. Weaknesses more expensive than using the current conventional retractor. So the intrinsic value f the benefits received must outweigh the additional costs of using the retractor developed by the sponsor. 0 Significant Initial Cost: The sponsor needs $1 1. MM – $MM initially to achieve profitability.
Worldwide sales are projected to be $MM in 2014 if a large sales partnership is attained, where sales numbers would fall to $31 M if the sponsor decides to proceed with direct sales. 0 Competition from Minimally Invasive Procedures: Indirect competition based on price, quality and service comes from minimally invasive surgical procedures developed to replace open-chest surgery (e. G. Angioplasty, stetting and harpsichord and robotic surgery). These techniques attract considerable press, including statements that there are now fewer open-chest procedures.
The US number of open-chest procedures has been nearly constant since 1995. Conclusion 16 Although minimally invasive surgical procedures developed to replace open chest surgery, have attracted considerable press, including statements that there are now fewer open-chest procedures (e. G. Angioplasty, stetting and thermoplastic and robotic surgery), minimally invasive procedures have at most limited the growth of open-chest surgery. The US number of open-chest procedures has been nearly instant since 1995.
In the last 10 years, there have been more than 10,000 16 Page 4 of 17 medical publications and billions of dollars spent on minimally invasive procedures. Yet despite this massive effort, less than 10% of all chest surgeries today are minimally invasive. Open chest procedures are widely used because they are the “Gold Standard” of surgical care and because surgeons are well acquainted with them. Surgeons have resisted adopting many minimally invasive procedures because of their high cost, increased technical complexity, and lengthy training for which practicing surgeons have very little time.
Further, minimally invasive procedures have achieved, at best, only marginal improvements over full access surgery. In contrast, the sponsor’s retractor will be an easy-to-use, inexpensive, drop-in replacement for current retractors, requiring almost no training. Furthermore, open-chest procedures are performed mostly on people older than 65, a group that will grow 50% by 2030 in the US and other developed nations. With a current US market of 600,000 and a US and European combined market of 1. 2 million open chest surgeries annually, further growth will be driven by the obesity/diabetes low.
Although using the device is expensive ($500 per use), the additional cost will be more than offset by shortened hospital stays ($750 to $1 500/ day) and reduced frequency of expensive complications. Retraction requires large forces that are generated with a thoracic retractor that is, simply, a mechanical Jack. Today’s thoracic retractors were developed in 1936. The medical community has long been seeking a solution to this problem to have a device that eliminates rib fractures, improves post- surgical respiratory function and decreases post-surgical pain. As Peter K.
Smith, Chief of Cardiovascular & Thoracic Surgery at Duke University mentioned, “There is a definite need for an improved sterna retractor. ” The sponsor’s products will be “drop-in replacements” for current instruments, which will streamline regulatory approval, simplify use, and drop barriers to acceptance. The products will not only benefit the hospital where current billing practices greatly reward hospitals that decrease the cost of post-surgical care, but the surgeon as well, resulting in an unchanged usage procedure that requires no additional training.
A device that delivers many of the improvements touted for minimally invasive urge with less intensive post-surgical care would free the surgeon’s time and provide increased patient satisfaction. The sponsor’s retractor has a robust design with reusable retractor and disposable parts for each surgery. There are different consumables for tracheotomy and for storerooms, with each possessing proprietary technology unique to each procedure. It will be a 510(k) device, the Fad’s least stringent level of regulatory approval, with claims of efficacy being possible after completion of successful clinical trials in 2013 as seen in Figure 2 below.
Based on ales projections and milestones for the next four years, similar companies have recently been acquired for $MM to $MM. Profitability in 2013 makes PIP an attractive alternative. Page 5 of 17 In summary, Physicist’s Assuage Retractor exhibits a host of compelling benefits and is anticipated to have good commercial potential. While compelling, the invention may still find adoption reluctance given the medical field is notoriously resistant to change. Physicist must identify and combat these adoption barriers through primary research followed by savvy market education.
Increasingly understanding the by- yes for retractors will also be paramount. Figure 1: Figure 2: – For Duke CT’ use only – Do Not Distribute ANALYSIS SUMMARY Centralization Factor Comments IP Strength Physicist has exclusively licensed U. S. Patent 7,775,974 82 from NC State. This patent covers the Force-Determining Retraction Device and Associated Method. Two Omnibus patents published and are now entering national filing phase. Multiple provisional filings will be completed as the technology develops.
Market Attractiveness In the US, approximately 600,000 open-chest surgeries are performed every year. These procedures are performed typically on people older than 65, a group that is expected to grow 50% by 2030. Additionally, a growing number of people are diagnosed with medical problems such as obesity and diabetes, which will cause an increase in the potential for open-chest surgeries. While the retractor market is large, steady, and ripe for innovation, input from surgeons regarding their appetite for adoption remains to be acquired.
Level of Development The basis of Physicist’s original technology was developed in 2004. Since then a prototype has been developed and tested in preclinical proof-of-concept. These trials roved fewer rib fractures, lower pain scores, decreased post-surgery respiratory rates, increased bloodying levels, less rescue analgesia required, and better overall recovery. Timing Since the original development of the most commonly used retractor in 1936 there have been no major improvements to retractor technology. A possible barrier is the industry focus on Minimally Invasive Surgeries (MIS).
However, currently only 10% of all chest procedures today are minimally invasive. Page 7 of 17 Hugh Cesareans CEO, Physicist, Inc. 919-413-7207 Hugh. [email protected] Com http://www. Linked. Com/in/hugeness’s Meeting date: 9/13/10 Those in attendance included DRP. Cesareans, his colleague Chuck Peel (CSS of Physicist, Inc. ) and the four members of the CT’ team. The meeting began with the DRP. Cesareans giving us his background information. Mr… Cesareans and Mr… Peel have lots of experience with successful start-ups and are very confident about the future success of Physicist.
The sponsors also asked for our background information, and seemed happy with the variety of experiences and interests that our team brings to this project. The sponsors then gave the CT’ team background about thoracic retractors, their use, ND why the existing machines are not satisfactory. Mr… Peel stated that existing retractors are practically “stone-age” technology, made up of simple pieces of steel with a manual crank that is used by the surgeons to force open the thoracic cavity. The latest minor innovation in the retractor market was that the crank no longer backtracks slightly after the surgeon lets go.
However, there have not been any substantial innovations to retractors since the sass (when the Finickiest retractor was introduced). The current state-of-the-art retractor was made by DRP. Antennae. Mr… Peel provided a demonstration of the current retractor to let us experience firsthand how difficult it is to use. DRP. Cesareans explained that current retractors do not incorporate any sensors that could quantify any forces, strain-rate, or stresses experienced by the patient’s bones and tissues as the retractor is used. This causes unnecessary damage, often in the form of damaged nerves and tissues and/or broken ribs.
Mr… Peel calculated that the force being put on a single rib during retractor use was greater that the weight of the average patient’s body. Soft tissues such as muscles and nerves do not respond well o sudden increases in stress/strain. Physicist’s improved thoracic retractor implements a sensor and feedback system that minimizes the trauma to the patient’s body during retraction. Physicist’s technology is “disruptive” in that it will probably have a significant impact on the way open-chest surgeries will be performed in the future.
The Sponsor believes that whoever has access to Physicist’s system will have a substantial advantage in the surgical device marketplace. The Sponsor concluded the meeting by informing the team that they had a discussion with representatives from the cardiovascular division at Monitored landed for later in the week. Background information about Monitored was to be provided to the Sponsor before that time so that the Sponsor could be well-prepared at the meeting. Meeting date: 9/27/10 The second meeting with the Sponsor began with the completion of non-disclosure agreements by all team members.
The team members then presented the executive summaries of the eighteen companies that had been researched. Of the four companies researched by Dairy (Invasive, Striker, Smith & Nephew, Telexed), she recommended conducting further research on Striker and Telexed. Striker has been having difficulty in their medical devices sector recently and might be looking for a way to improve this segment in the coming year. The Sponsor commented that Striker is probably backed up for the time being with troubles from the FDA and reorganizing the way that they handle acquisitions.
Telexed has been moving more towards the medical devices side, and DRP. Cesareans mentioned that their local (Research Triangle Park) headquarters would be a potential benefit of working with that company. Alyssa companies included Chivvied, SST Jude Medical, Integrate, and Edwards Lifelessness. SST Jude Medical is not a good option for Physicist because they don’t operate in the surgical devices market. Chivvied is a possible candidate, but they are somewhat invested in millenarianism techniques so may not be an optimal target company.
Integrate has already has thoracic retractors, but of a different type (ring retractors and wishbone retractors). There is some question as to how this would affect their interest in Physicist’s technology. The Sponsor asked for the details of Integral’s acquisition of Omni-Tract International, the makers of their debutantes retractors. Specifically, Mr… Cesareans was interested in the purchase price. Finally, Edwards Lifelessness is a less likely candidate because of their sparse track record for acquisitions, but they do make soft-tissue retractors that could potentially utilize Physicist’s technology.
The Sponsor has asked for more information on this as well. The four companies researched by Tandem are Boston Scientific, the Scorn Group, Micromole, and Carousing. Tandem did not recommend Boston Scientific because of their recent problems and he was not able to find substantial information on Micromole because they are a private company. Carousing has not been doing well manically, but the Sponsor would like to know what initiatives the company is pursuing to help turn their revenues around for next year. The most promising of the companies is the Scorn Group.
They have solid financial and the Sponsor pointed out that their recent patterns of acquisitions and divestment reveal that they see their strengths in open cardiac surgery rather than minimally invasive. Mr… Cesareans thinks that acquiring retractors may be a good opportunity for them. Tom researched five companies, of which Johnson & Johnson has the most potential. They have a far reach in the market and want to release 80 new innovative products ever the next 2 years. Manqué is another possible target company that has had several recent acquisitions. Mr… Cesareans would like to know whether they have any connections with Duke.
Tom did not recommend pursuing relationships with Calculates (tight financial) or Cook Medical (no surgical devices). Finally, limited information was available for KILLS Martin because it is a private company. The sponsors will use the next week to digest this information and decide which page 9 of 17 continue moving forward with. He informs the group that Physicist’s meeting with Monitored went as well as could be hoped for an initial conversation. At the next meeting the Sponsor will provide the team with more detailed information about Physicist’s technology.
MARKET RESEARCH SUMMARY The following articles and market research report excerpts provide insights into the markets for this technology: There are 600,000 open-chest surgeries in the United States each year. This number doubles to 1. 2 million surgeries each year when you include the European countries. These open-chest procedures are needed for coronary artery bypass grafting (CAB), heart valve repair or replacement, the removal of lung cancer, and other thoracic cavity procedures. The expenditures in the United States alone for cardiac surgery are $30 billion dollars.
The majority of this cost is attributed to post-operative care, and not the surgical procedure itself. While much of the industry is looking towards minimally invasive techniques, the standard for gaining access to the chest cavity is still and will continue to be storerooms and tracheotomy. Growth of the general surgery market will be propelled by robotic devices and computer assisted surgical devices. 17 In the U. S. Alone the market grew by 3% in 2009 to reach a value of $121. 3 billion, and is expected to grow to $146. Billion by 2014.
This does indicate a deceleration in the compound annual growth rate (CARR) to 3. 9% for 2009-2014 from 5. 7% for 2005-2009. 18 Bypass is better than angioplasty for severe heart disease: Why, how and what to do Los Angels Times September 10, 2010 http://www. Lattices. Com/health/la-sic-bypass-angioplasty-20100912,0,630173. Story Tens or even hundreds of thousands of Americans are having coronary artery angioplasty and stetting every year when they should be having bypass grafts, and the result is an extra 5,000 or more deaths annually, researchers said Sunday.